Download as pdf or txt
Download as pdf or txt
You are on page 1of 261

SERVICE 

MANUAL
Rev. 1 (ENG)
Copyright and License

Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowed
under the copyright laws.

The information contained herein is subject to change without notice.

The only warranties for ALPINION products and services are set forth in the express warranty statements
accompanying such products and services. Nothing herein should be construed as constituting an additional
warranty. ALPINION shall not be liable for technical or editorial errors or omissions contained here in.

Prepared by:
ALPINION MEDICAL SYSTEMS Co., LTD.
1FL and 6FL, Verdi Tower,
72, Digital-ro (St) 26-gil (Rd),
Guro-gu, Seoul, Republic of Korea

1316~1320 room, ACE HIGH-END Tower 1st,


5, Digital-ro (St) 26-gil (Rd),
Guro-gu, Seoul, Republic of Korea 152-848

T: +82 2 3282 0907 F: ++82 2 851 5591 www.alpinion.com


Copyright © 2012 ALPINION MEDICAL SYSTEMS Co., LTD, All rights reserved.

70000916 Rev. 01

1
Revision Log

The following is a list of major changes and additions that have been made to this manual since it was first
released.

See the accompanying Release Notes for specific changes to the software and hardware between manual
updates.
Rev Date Description
Rev. 0 July 10, 2012 Service manual first released
Rev. 1 Nov 5, 2012 Updated for Rev. 1 release

2
Table of Contents
PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

CHAPTER 1. PREPARING FOR INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1-1 Environmental Requirements ........................................................................................................................................ 9

1-2 Electrical Requirements ............................................................................................................................................... 11

1-3 EMI Limitations .............................................................................................................................................................. 13

1-4 Facility Requirements ................................................................................................................................................... 14

1-5 Networking Requirements ........................................................................................................................................... 15

CHAPTER 2. INSTALLING YOUR SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 7

2-1 Safety Information ........................................................................................................................................................ 18

2-2 Average Installation Time ........................................................................................................................................... 19

2-3 Unpacking ...................................................................................................................................................................... 20

2-4 Verifying the Customer Order .................................................................................................................................... 24

2-5 Configuring the System Settings ............................................................................................................................... 29

2-6 Specifications ................................................................................................................................................................. 30

CHAPTER3. CHECKING FUNCTIONS OF YOUR SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2

3-1 Necessary Equipment................................................................................................................................................... 43

3-2 General System Functions ........................................................................................................................................... 43

3-3 Monitor Functions ........................................................................................................................................................ 63

3-4 Mechanical Functions ................................................................................................................................................... 65

3-5 Board Functions ............................................................................................................................................................ 68

CHAPTER 4. COMPONENTS AND FUNCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 9

4-1 General Information ..................................................................................................................................................... 70

4-2 Block Diagram ............................................................................................................................................................... 71

3
4-3 Segment Functional Descriptions .............................................................................................................................. 72

4-3-5 Power Supply Unit (PSU) ......................................................................................................................................... 76

4-3-6 Keyboard and Control Panel ................................................................................................................................... 76

4-3-7 Peripherals .................................................................................................................................................................. 77

4-4 Service Platform ............................................................................................................................................................ 85

CHAPTER 5. REPLACING COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3

5-1 Disassembly and Reassembly ..................................................................................................................................... 94

5-2 System Software Installation .................................................................................................................................... 155

5-3 Finishing ....................................................................................................................................................................... 175

CHAPTER 6. RENEWAL PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 7 6

6-1 List of Renewal Parts .................................................................................................................................................. 177

6-2 Power Supply Unit ...................................................................................................................................................... 179

6-3 Air Filter ........................................................................................................................................................................ 180

6-4 Control Panel ............................................................................................................................................................... 181

6-5 Covers ........................................................................................................................................................................... 182

6-6 TI/FE............................................................................................................................................................................... 183

6-7 Frame ............................................................................................................................................................................ 184

6-8 Cables ............................................................................................................................................................................ 185

6-9 HDD ............................................................................................................................................................................... 186

6-10 IO ................................................................................................................................................................................. 186

6-11 Monitor ....................................................................................................................................................................... 187

6-12 Probe (Transducer) ................................................................................................................................................... 188

Chapter 7. System .............................................................................................................................................................. 189

7-1 System Care and Maintenance ................................................................................................................................. 189

7-2 Transducer Care and Maintenance .......................................................................................................................... 194

4
C H A P T E R 8 . S A F E T Y A N D R E G U L A T O R Y I N F O R M A T I O N. . . . . 1 9 9

8-1 Safety Summary .......................................................................................................................................................... 200

8-2 Important Safety Warnings ...................................................................................................................................... 201

8-3 Patient Safety Information ........................................................................................................................................ 202

8-4 Electrical Safety Information .................................................................................................................................... 203

8-5 Transducer Safety Information ................................................................................................................................. 204

8-6 System Symbols and Labels ...................................................................................................................................... 206

8-7 Regulatory Information ............................................................................................................................................. 209

8-8 Electromagnetic Compatibility (EMC) ..................................................................................................................... 210

8-9 Peripheral Update for EC Countries ........................................................................................................................ 258

5
Preface
How to use this manual
This manual provides you with necessary information on installing and servicing the E-CUBE
7 ultrasound system.

Who should use this manual


This manual is intended for authorized service representatives and hospital’s service
personnel who are responsible for servicing the E-CUBE 7 ultrasound system.

How this manual is organized


This manual is organized as follows:

 Chapter1, Preparing for Installation describes preparations and requirements for


installing your system.

 Chapter2, Installing Your System describes how to install your system.

 Chapter3, Checking Functions of Your System describes how to check major functions
of your system after the installation is finished.

 Chapter4, Components and Functions describes each component and function of your
system.

 Chapter5, Replacing Components provides procedures for replaceable components.

 Chapter6, Renewal Parts provides lists of replaceable parts in each component.

 Chapter7, Care and Maintenance provides how to care and maintain your system.

 Chapter8, Safety Information provides general safety precautions that must be observed
while operating and maintain the system.

6
Manual conventions
Before you start, be familiar with the following manual conventions that are commonly used
in this document:

Convention Meaning
Bold Qwerty keyboard keys, keys on the control panel, and
switches on the system
Buttons and dialog boxes on the user interface
windows
Italic Names of user interface windows

> The order of menus you must select to perform a


specific function

Document feedback
We have made every effort to ensure the accuracy and completeness of this document.
However, if you find an error or an omission, or you think that a topic needs further development,
we want to hear from you. Forward your feed back to:

www.alpinion.com

Provide the title and version number of this manual and as much detail as possible about your
comment, including the topic heading and page number and your suggestions for improvement.

7
Chapter 1. Preparing for Installation
This chapter describes necessary requirements to prepare for installing a new E-CUBE 7.
Before installing the system, you should consider all of the following requirements:

 Environmental Requirements

 Electrical Requirements

 EMI Limitations

 Facility Requirements

 Networking Requirements

8
1-1 Environmental Requirements
In an ultrasound room, check the following environmental requirements first to make the system
work properly.

WARNING :
Using the system in an inappropriate environment might cause unexpected problems

You should use this system in proper environment to prevent it from radio wave interference,
dust and gas. Make sure the area, which your system is installed, is well‐ventilated, with a
temperature, humidity, and pressure requirements. If the system is exposed to inappropriate
temperature, humidity, or pressure, adapt your system to normal range of environment for a few
hours.

1-1-1 Environmental requirements for system


Temperature Humidity Pressure
Operation 10 °C ~ 35 °C 30 % ~ 75 % 700 ~ 1060 hPa
Storage -25 °C ~ 60 °C 20 % ~ 90 % 700 ~ 1060 hPa
Transportation -25 °C ~ 60 °C 20 % ~ 90 % 700 ~ 1060 hPa

CAUTION :

Before powering the system on, make sure that the system meets the operational conditions
in temperature and humidity.

9
1-1-2 Environmental requirements for ultrasound room
Item Values

Power source See Electrical Requirements.

Current rating 7.5A (100V-120V); 3.5A (200-240V)

Radiation Not required


shielding
Temperature 20 – 28 °C (68 – 79 °F)

Humidity 50 – 70%

Heat dissipation 2000 BTU/hr

Floor landing About 680 – 800 kg/m2 without accessories

Floor condition Gradient within 10 degrees

Cooling 2000 BTU/hr

Lighting Combination lighting (Dim and bright)

 Powering On/Off

Power on

• Turn on the System On/Off switch on the bottom rear of the system. Press the Power
On/Off key on the control panel to turn on the system power

CAUTION:

• Make sure that the power cord is plugged into the power outlet, and the system
power is supplied from a separate and properly rated power outlet.

• Do not unplug the power cord during the system operation. Do not push the
System On/Off switch before pressing the Power On/Off key. This may lead to
data loss or system software damage.

• Depending on the power-off setting. You can activate Sleep mode or turn the
system off immediately. To change the power-off setting, press the System
Preset key and go to System > General > Power off.

Power off

• Press the Power On/Off key on the control panel to turn the power off. When the
shutdown dialog box appears, select Shutdown by using Trackball.

10
1-2 Electrical Requirements
 Sites with a mains power system with defined neutral and live:
The dedicated line shall consist of one phase, a neutral (not shared with any other circuit), and a
full size ground wire from the distribution panel to the Ultrasound outlet.

 Sites with a mains power system without a defined neutral:


The dedicated line shall consist of one phase (two lines), not shared with any other circuit, and a
full size ground wire from the distribution panel to the ultrasound outlet.

NOTE:
Please note that image artifacts can occur, if at any time within the facility, the ground from the
main facility's incoming power source to the ultrasound unit is only a conduit.

1-2-1 Power requirements


Before installing the system, you need to check the following power requirements.

Parameter Area Limit


Voltage range 100 – 120V 100 – 120 VAC ± 10% (90-132 VAC)
200 – 240V 200 – 240 VAC ± 10% (180-264 VAC)
Power All applications MAX. 650 VA with Built-in and On-Board
Peripherals
Line frequency All applications 50/60 Hz (± 2Hz)
Power transients All applications Less than 25% of nominal peak voltage for less
than 1 millisecond for any type of transient,
including line frequency, synchronous,
asynchronous, or aperiodic transients
Decaying All applications Less than 15% of peak voltage for less than 1
oscillation millisecond

1-2-2 Site circuit breaker


The branch circuit breaker is recommendable for the system.

CAUTION:
To prevent the system from power outage or circuit overload, do not use the same circuit with
another machine.

11
1-2-3 Site power outlets
The AC power outlet should exist within reach of the system. Also, peripheral devices and all
other medical equipments should be placed within 1m (3.2 feet) of the system. Avoid using
extension cord to connect to the system.

1-2-4 Unit power plug


When the system comes with the wrong plug, contact your local agent for replacement.

1-2-5 Power stability requirements


 Voltage drop-out: Max 10 ms

 Power Transients (for all applications): Less than 25% of nominal peak voltage for
less than 1 millisecond for any type of transient, including line frequency, synchronous,
asynchronous, or aperiodic transients

12
1-3 EMI Limitations
The ultrasound system is sensitive to Electromagnetic Interference (EMI) from radio frequencies
(RF), magnetic fields, and transient in the air wiring. Before installing the system, consider
possible EMI sources from electrical and electronic machines nearby the ultrasound system. The
possible EMI sources are from: medical lasers, scanners, cauterizing guns, computers, monitors,
fans, gel warmers, microwave ovens, light dimmers, mobile phones.
The following descriptions are tips to prevent your system from unintentionally exposing EMI:

 Be aware of RF sources.

 Ground the unit.

 Replace all screws, RF gaskets, covers, and cores.

 Replace broken RF gaskets.

 Do not place labels where RF gaskets touch metal.

 Use specified harnesses and peripheral machines.

 Take care with mobile phones.

 Properly dress peripheral cable.

13
1-4 Facility Requirements
1-4-1 User requirements
A user (or a purchaser) needs to prepare required materials and pay additional costs (if
necessary) before an ultrasound system is delivered and installed.

NOTE:
The desire to use a non-listed or customer provided product or to place an approved product
further from the system than the interface kit allows presents challenges to the installation team.
To avoid delays during installation, such variances should be made known to the individuals or
group performing the installation at the earliest possible date (preferable prior to purchase).

1-4-2 Feature requirements


 Dedicated single branch power outlet of adequate amperage meeting all local and national
codes which is located less than 2.5 m (8 feet) from the unit’s proposed location
 Door opening is at least 76 cm (30 inch) wide
 Proposed location for unit is at least 0.3 m (1 foot) from the wall for cooling
 Power outlet and place for any external peripheral are within 2 m (6.5 feet) of each other
with peripheral within 1 m of the unit to connect cables.

1-4-3 Additional recommendations


The following facility features are additionally desirable for better performance of your system.

 Door is at least 92 cm (3 feet) wide

 Circuit breaker for dedicated power outlet is easily accessible

 Sink with hot and cold water

 Receptacle for bio-hazardous waste, like used transducer sheaths

 Emergency oxygen supply

 Storage for linens and equipment

 Nearby waiting room, lavatory, and dressing room

 Dual level lighting (bright and dim)

 Lockable cabinet for the system software and proprietary manuals

14
1-5 Networking Requirements
1-5-1 Purpose of DICOM network function
The DICOM service provides clinically useful features for moving images and patient
information over a hospital network. The DICOM service includes the transfer of images
to workstations for viewing or transferring images to remote printers.

1-5-2 Pre-installation Requirements


To configure the E-CUBE 7 to work with other network connections, the field’s network
administrator must provide some necessary information.
Information must include:
- A host name, local port number, AE title, IP address and subnet mask for the E-
CUBE 7

- The IP addresses for the default gateway and other routers at the site for routing
information

Figure 1-1 General

Figure 1-2 Storage

15
Figure 1-3 Commitment

Figure 1-4 Print

Figure 1-5 Worklist

16
Chapter 2. Installing Your System
This chapter introduces the basic install information and procedures when the new
equipment arrives at the site of a purchaser. Performing installation includes safety
considerations, unpacking and installing the system, and verifying hardware/software
specifications.

 Safety Information

 Average Installation Time

 Unpacking

 Verifying the Customer Order

 Powering On/Off

 Configuring the System Settings

 Specifications

17
2-1 Safety Information
The following note, cautions, and warnings describe safety information before or while
installing the system.

NOTE
Read the user manual carefully before operating the system. For quick reference, keep the
manual nearby the equipment.

WARNING
Do not touch the equipment while testing the AC ground line with a test instrument.

CAUTION
The equipment weighs approximately 57kg without any peripherals. To prevent injury from
transporting and unpacking the equipment, two people are required.

CAUTION
Adapt the equipment to room temperature first after transporting it. Turning on the system may
cause damage before adapting the equipment. The following table shows the different
adaptation time depending on the actual temperature of the equipment after it is being
transported. The maximum adaptation time is up to 24 hours.

Table 2-1 Acclimation time


°C 60 55 50 45 40 35 30 25 20 15 10 5 0 -5 -10 -15 -20 -25 -30 -35 -40

°F 140 131 122 113 104 96 86 77 68 59 50 41 32 23 14 5 -4 -13 -22 -31 -40

hr 8 6 4 2 0 0 0 0 0 0 0 2 4 6 8 10 12 14 16 18 20

CAUTION
Connect the unit to a safely grounded power outlet to prevent any electrical shock. Do not use
a two to three prong adapter for safety grounding.

CAUTION
Make sure that all board covers and frame panels are securely in place before operating the
equipment. This may affect system performance and cooling.

CAUTION
Do not wear an ESD wrist strap while working on live circuits.

CAUTION
Do not use a 20 Amp to 15 Amp adapter on the 120 Vac unit’s power cord. This unit requires a
dedicated 20A circuit and can have a 15A plug if the on board peripherals do not cause the
unit to draw more than 14.0 amps.

CAUTION
Although the ultrasound energy transmitted from your transducers is within FDA limits, avoid
unnecessary exposure. Ultrasound energy may produce heat and mechanical damage.

18
2-2 Average Installation Time
The average installation time for an experienced service engineer is about 2 hours.
The following table shows the average installation time by an experienced service engineer.
Note that this is based on the original equipment and the time may take longer depending on
the optional equipment.

Table 2-2 Average installation time


Category Average time Comment
Unpacking the system 20 minutes
System installation with 20 minutes Dependant on the required configuration
no options
Network options 30 minutes Dependant on the required configuration

WARNING
Do not remove any covers or panels, to prevent shock. If it problems or malfunctions occur,
unplug the power cord from the outlet.

19
2-3 Unpacking
When new equipment arrives, check all components are included in the package and they are
not damaged. If any component is damaged or excluded, contact your local agent.

To unpack the equipment,

1. Cut the plastic bands on the package by using your scissors or cutter.

Figure 2-1 Cutting the plastic bands

2. Lift the top cover up.

Figure 2-2 Removing the top cover

20
3. Unscrew the plastic joints and remove them from the outer sleeve.

Figure 2-3 Removing Plastic Joints

4. Remove the outer sleeve.

Figure 2-4 Removing sleeves

21
5. Remove the soft foam that covers up the monitor and option boxes.

Picture 2-5 Removing soft foam

6. Remove the plastic bag that surrounds the equipment.

7. Remove the plastic tapes on the palette and drop down the wooden board.

Figure 2-6 Moving the system from the crate

8. Release the front and rear caster locks, and then slide the equipment off the palette.

9. Slowly move the equipment to its position in the ultrasound room.

22
CAUTION:
1. Do not lift the equipment by holding the control panel or any cover. The equipment may be
damaged.
2. While moving the equipment, be very carefully not to tilt the unit over. To avoid injury from
the tipping over, keep the monitor at the lowest position.
3. Store all loose parts of the units in a separate place to prevent damage before moving. For
transducers, wrap them in soft cloth or foam.

23
2-4 Verifying the Customer Order
When you are finished with unpacking the equipment, you need to verify all items listed in the
delivery sheet. If any component is missing or damaged, contact your local agent.

2-4-1 Power on/off


2-4-1-1 Power on
Before powering the system on, make sure that the voltage setting is correct for the system.
Check the both voltage selectors for I/P and O/P on the rear of the system.

1. Make sure that the power outlet is proper type.

CAUTION:
 When connecting the AC power cable without its plug to the wall outlet, protective earth
should be taken.
 Make sure that the system power is supplied from a separate and properly rated power
outlet.

2. Make sure that the System On/Off switch is turned off.


3. Plug the power cord into the power outlet.
4. Turn on the System On/Off switch on the bottom rear of the system

Figure 2-7 Circuit breaker

24
5. Press the System On/Off key on the control panel to turn on the system power.
The start-up screen is shown on the display and the system is initialized.

Figure 2-8 Power on/off key

NOTE
To reboot the system, wait for a few seconds before powering on the system.

2-4-1-2 Power- screen sequence

1. The start-up screen will be shown on the monitor when the system is powered on.

Figure 2-9 Start-up screen display

2. When the system boots, all keys on the control panel are lighted the default 2D mode screen
or patient screen is shown on the display.

25
2-4-1-3 Power off

1. Press the Power On/Off key on the control panel to turn the power off.
2. When the shutdown dialog box appears, select Shutdown by using Trackball.
NOTE: Depending on the power-off setting, you can activate Sleep mode or turn the
system off immediately. To change the power-off setting, press the System Preset key and
go to System > General > Power Off.

CAUTION:
Do not unplug the power cord during the system operation. Do not turn off the System
On/Off switch before pressing the Power On/Off key. This may lead to data loss or system
software damage.

Figure 2-10 Shutdown dialog box

2-4-1-4 Connecting/Disconnecting the transducer

You can connect or disconnect the transducer to/from the transducer port regardless of
when the system is turned off or on. Make sure that you press the Freeze key on the
control panel before connecting or disconnecting the transducer.

26
To connect the transducer to the system, follow these steps:

CAUTION :
Do not touch the patient when connecting or disconnecting a transducer.

1. Check if you press Freeze key on the control panel.

Figure 2-11 Connecting the transducer

2. Insert the transducer connector into the transducer port.


CAUTION :
Do not forcibly insert the transducer connecter to the system. Improper connection may
cause damage to the system and transducer.

3. Turn the connector locking handle clockwise.

Figure 2-12 Connecting the transducer

NOTE: After connecting the transducer to the system, you need to activate the desired
transducer by selecting it from the screen.

27
You can disconnect the transducer from the transducer port when the system is powered off
or on. Make sure that you press the Freeze key on the control panel before disconnecting
the transducer.

To disconnect the transducer from the system, follow these steps:

1. Check if you press the Freeze key on the control panel.


2. Turn the connector locking handle counter-clockwise.
3. Pull out the transducer connector from the transducer port.

CAUTION:
Do not touch the exposed surface of the transducer connector when the transducer is removed.

28
2-5 Configuring the System Settings
Configure the system’s basic settings such as date, time, language, and basic user information.

1. Press the System Preset key on the control panel.

2. From the General category, set the basic information such as the organization, hospital,
department, language, and date & time.

3. Click Save to save the settings.

4. Click Exit.

Figure 2-13 System preset screen

29
2-6 Specifications
This section introduces specifications of the system and other peripheral devices.

4
5
Figure 2-14 E-CUBE 7

1. Monitor
2. Monitor Arm
3. Body Cover
4. Body base
5. Wheel and control pedal

30
2-6-1 Physical dimensions
• 2-6-1-1 E-CUBE 7

The following table shows the physical specifications of E-CUBE 7, with monitor and
peripherals.
.

Table 2-2 Physical dimensions

Height Width Depth Unit


1355 / 1425 509 670 mm
53.35 / 56.1 20.04 26.38 inch

WEIGHT: 57kg (125.66lbs) including Monitor

NOTE: Length is in mm Variation: +/-10%

Figure 2-15 System dimensions

31
2-6-2 Electrical specifications
Table 2-3 Electrical specifications
System Voltage Current Frequency
E-CUBE 7 110/220 VAC 5~7A 50~60 Hz

2-6-3 Optional peripherals


The following table shows the list of optional recording devices. Refer to the each
manufacturer’s manual for installation and connection procedures.

Table 2-4 List of optional peripherals

Device Manufacturer Model Signal type Video signal


B/W Printer SONY UP-897MD Analog (BNC Interface)
B/W Printer SONY UP-D897 Digital (USB Interface)
B/W Printer MITSUBISHI P95DE Digital (USB Interface)
Color Printer SONY UP-D25MD Digital (USB Interface)
Color Printer SONY UP-25MD Analog (BNC Interface)
DVR SONY DVO-1000MD Digital/Analog (RS232 & S-Video
Interface)

NOTE: There are no external peripheral options.

32
2-6-4 External I/O connector panel
I/O panel located on the rear side of the system includes video input and output connectors,
audio input and output, USB, power connector and control connections for VCR or DVD
recorder, and printer.

Figure 2-17 External I/O connector panel

No. Peripheral Name

1 Analog Monitor
2 AV Selector
3 DVI monitor
4 Analog Monitor
5 Memory Stick
6 LAN Cable
7 LED BOX
Table 2-5 Signal description

Figure 2-16 External I/O connector panel

33
2-6-5 External I/O pin outs
Table 2-6 Pin Assignments of USB

Pin Signal
1 VCC
2 Data-
3 Data+
4 GROUND

Signal Pin Description I/O


VCC 1 +5V power supply P 5V
-DATA 2 Universal Serial Bus I/O USB
Data, negative
different signal
+DATA 3 Universal Serial Bus I/O USB
Data, positive different
signal
GND 4 Ground

Table 2-7 Pin assignments of peripherals y signal and composite signal


Y (BW)
Pin Signal
1 Y_OUT
2 GROUND

Composite (Color)
Pin Signal
1 COMPOSITE_OUT
2 GROUND

Table 2-8 Pin assignments of S-Video In/Out connector

S-Video

Pin Signal
A1 GROUND
A2 GROUND
A3 Y_OUT
A4 C_OUT
B1 GROUND
B2 GROUND
B3 Y_IN
B4 C_IN

34
Table 2-9 Pin Assignments of VGA out Connector

VGA
Pin Signal
1 RED
2 GREEN
3 BLUE
4 NC
5 GROUND
6 GROUND
7 GROUND
8 GROUND
9 DDC_POWER
10 GROUND
11 NC
12 DDC_DAT
13 HSYNC
14 VSYNC
15 DDC_CLK

35
Table 2-10 Pin Assignments of DVI out Connector

DVI
Pin Signal Function
1 TMDS Data2-
2 TMDS Data2+
3 TMDS Data2/4 Shield GROUND
4 TMDS Data4- N/A
5 TMDS Data4+ N/A
6 DDC Clock [SCL]
7 DDC Data [SDA]
8 Analog vertical sync N/A
9 TMDS Data1-
10 TMDS Data1+
11 TMDS Data1/3 Shield GROUND
12 TMDS Data3- N/A
13 TMDS Data3+ N/A
14 +5 V Power
15 Ground (for +5 V) GROUND
16 Hot Plug Detect
17 TMDS Data0-
18 TMDS Data0+
19 TMDS Data0/5 Shield GROUND
20 TMDS Data5- NC
21 TMDS Data5+ NC
22 TMDS Clock Shield GROUND
23 TMDS Clock +
24 TMDS Clock -
C1 Analog Red N/A
C2 Analog Green N/A
C3 Analog Blue N/A
C4 Analog Horizontal Sync N/A
Analog GND Return: (analog R,
C5 N/A
G, B)

36
Table 2-11 Pin Assignments of LAN Port

LAN

Pin Signal Function


1 TD+
2 TD-
3 CT0 N/A
4 CHS GROUND
5 CHS GROUND
6 CT1
7 RD+
8 RD-

37
Table 2-12 Pin assignments of Audio In/Out connector

AUDIO
Pin Signal
A1 GROUND
A2 LINE_IN_LEFT
A3 LINE_OUT_LEFT
B1 GROUND
B2 LINE_IN_RIGHT
B3 LINE_OUT_RIGHT

38
2-6-6 Connectivity installation worksheet

Figure 2-17 General page

Figure 2-18 Storage page

39
Figure 2-19 Commitment page

Figure 2-20 Print page

40
Figure 2-21 Worklist page

41
Chapter3. Checking Functions of Your System
This chapter introduces major functions of the system that you need to check after the
installation. By verifying the each part of the hardware and software functions, make sure
that your system works properly.

 Necessary Equipment

 General System Functions

 Monitor Functions

 Mechanical Functions

 Board Functions

42
3-1 Necessary Equipment
Before the verification, check if the following equipments are available:

 An empty DVD-R or CD-R disk, USB drive


 At least one transducer

3-2 General System Functions


This section provides you with the basic functions of the equipment. Check the functions and
features by the following sequences.

3-2-1 Power on/off function checks


The power is distributed to the PSU Assy and power control in the Power assy.
When you press the Power On/Off key, the PSU Assy is enabled and feed each power to
board assemblies and system run the software.
For power on/off procedures, see Power on/off in chapter 2.

NOTE:
After turning off the system, wait for a while before turning it on again. If power is recycled
too fast, the system may not be able to boot up.

43
3-2-2 Control panel function checks

4D

Figure 3-1 Control panel layout

44
Table 3-1 Key description
No. Controls Description

1 Power on/off Use this control to turn on and off the system.

2 QWERTY keyboard Use this control to type numeric values and texts.

Use this control to display the Patient Registration


Patient
screen. You can enter patient data.
Use this control to select the desired transducer,
Transducer
application, and preset.
3
Use this control to create a report based on the exam
Report
result and edit it.
Use this control to activate image management with
E-view
end of study options.
Use this control to select or adjust the functions in
the soft menu at the bottom of the display.
4 Soft keys • Press to select the corresponding soft menu.
• Rotate to adjust the function of the
corresponding soft menu.
5 TGC slides Use these controls to adjust TGC values on images.
4D Use this control to activate 4D mode. This control
6
is optional.
Gain Use this control to adjust the gain function of the
7 current image.
Imaging mode Use these controls to activate 2D, PD, M, PW, CF, or
8 3D/4D modes.
Image layout Use these controls to view an image in dual, single,
9 or quad screen.
Panoramic • Use this control to acquire two-dimensional
ultrasound images with a composite, extended
field of view.
10 • The panoramic imaging is an option. If you do
not install this option, this panoramic control is
not activated.

Depth Use this control to adjust the scanning depth of an


image.
Focus Use this control to focus on the area of interest.
11
Zoom Use this control to turn Zoom mode on.
• Rotate to activate Read zoom.
• Press to activate Write zoom in Read zoom mode.

45
Body Pattern Use this control to display the body pattern images

Arrow Use this control to display an arrow pointer on the


screen.
Text Use this control to annotate images.
PW angle Use this control to change a PW angle.

12 Update Use this control to update a 2D image in real time


based on the specified time or freeze a 2D image.
PD Use this control to activate Power Doppler mode
Active mode Use this control to adjust parameters for each mode
in the duplex or triplex mode.

THI Use this control to turn harmonic imaging on and off.

Xpeed Use this control to automatically optimize image


parameters on the live screen.
13 User (1~2) Use these controls to access user-defined functions.
Cursor Use this control to show the cursor on the screen.
You can select a menu on the screen using this
cursor.
Clear Use this control to delete the arrow, comment, and
measurement.
Measure Use this control to perform measurement.

14 Priority Use this control to adjust the priority of Trackball.


• In 2D mode, press to select the priority between
the width and tilt functions.
• In Duplex or Triplex mode, press to select the
priority between ROIs of the activated imaging
modes.
Set Use this control to set the current function.
15 P1, P2 Use this control to print out.
Exit Use this control to exit current screen (mode) and
16
return to the previous screen (mode)
Use this control to select the desired function from the
17 Select
context menu on the screen.
Use this control to scroll through menus or options on
18 Trackball
the screen by moving the cursor.
19 Freeze Use this control to start and stop scanning.
20 Print Use this control to print out.

46
3-2-3 Image display function checks
The image screen displays an image, application information, patient information, and
indicators.

Figure 3-2 Image display

1. Company logo
2. Hospital logo
3. Hospital name, current date, time
4. Patient ID, patient name
5. Operator ID, transducer name
6. Mechanical index, thermal index
7. Zoom reference window
8. Context menu (Submenu for mode control)
9. Depth scale bar
10. Focus mark
11. Image parameter
12. Gray scale bar
13. The location of transducer
14. Soft key menu (main menu for mode control)
15. Clipboard indicator
16. Clipboard area
17. Clipboard icons(Recycle Bin, single layout format, dual layout format)
18. Caps lock, symbol lock, USB connection, network connection
19. Cine bar

47
3-2-4 Imaging modes checks
Verify function in each imaging mode of your system.

3-2-4-1 2D mode and M mode checks

Table 3-2 2D mode and M mode functions


Image optimization Functions
controls
Gain To increase or decrease the amount of echo information
displayed in an image. It may have the effect of brightening or
darkening the image if sufficient echo information is generated.

Depth Increasing the depth enables the deeper structures to be


visualized. You can decrease the depth if you do not need the
bottom portion of the display.

Focus You can tighten up the beam for a specific area by either
increasing the number of focal zones or moving the focal
zone(s). A graphic caret corresponding to the focal zone
position(s) appears on the right edge of the image.

Zoom Turn the Zoom key to activate Read Zoom and press the
Zoom key to activate Write Zoom. Use Read Zoom to get to
the area of Interest and then use Write Zoom to zoom in or
out.
Time Gain Compensation TGC amplifies returning signals to correct for the attenuation
(TGC) caused by tissues at increasing depths. TGC slide pots are
spaced proportionately to the depth. The area each pot
amplifies varies as well. A TGC curve may appear on the
display (if preset), matching the controls that you have set
(except during zoom). You can choose to deactivate the TGC
curve on the image.
Harmonic Harmonics enhances near field resolution for improved small
parts imaging as well as far field penetration by Digitally
Encoded Ultrasound (DEU). Harmonics reduces low frequency
high amplitude noise. Turning on this feature may be beneficial
when imaging isoechoic lesions in shallow-depth anatomy in
the breast, liver, and hard-to-visualize fetal anatomy.
Harmonics may improve 2D mode image quality without
introducing a contrast agent.
Frequency In multi frequency mode, you can change the frequency to the
transducer's next lower frequency or higher frequency.

Dynamic Range The ratio of the largest to smallest signals that an instrument
or a component of an instrument can respond to without
distortion.
In diagnostic ultrasound the dynamic range frequently is
expressed in decibel.
Dynamic Range is useful for optimizing tissue texture for
different anatomy. Dynamic Range should be adjusted so that
the highest amplitude edges appear as white while lowest
levels (such as blood) are just visible.

48
Rejection Elimination of low-amplitude signals from the display, also
known as noise rejection.
Up/Down Flips the image 180 degrees up/down.
Gray Map Press Gray Map to select a map. Gray maps gradually change
from least contrasty to most contrasty.

Colorize To enhance the user’s ability to distinguish B, M, and Doppler


Mode intensity valuations, the Colorization of a conventional
B-Mode image or Doppler Spectrum is used. Colorize is NOT
a doppler mode.

Edge Enhance Edge Enhance brings out subtle tissue differences and
boundaries by enhancing the gray scale differences
corresponding to the edges of structures. Adjustment to M
mode's edge enhancement affects M mode only.
Scan Area You can widen or narrow the size of the sector angle to
maximize the image's region of interest (ROI). Increase the
sector angle to see a wide field of view; decrease the sector
angle when you need to have a faster frame rate, as in fetal
heart.
Line Density Optimize 2D-mode frame rate or spatial resolution for the best
possible image. A lower line density is useful in fetal heart
beat, adult cardiac applications and in clinical Radiology
applications requiring significantly higher frame rates. A higher
line density is useful in obtaining very high resolution (e.g.
thyroid, testicles)
Dual and quad imaging Using dual imaging, you can position two images side-by side
on the display. Dual imaging is available in all 2D live imaging
Modes, M-mode, and Color Flow.
Sweep speed (M mode During M mode imaging, you can change the speed of the
only) sweeping display by turning Speed, a Soft Key display.
There are six sweep speeds: 0, 1, 2 , 3, 4, 5.
The sweep speed is displayed on the Soft menu window.

M-Mode Zoom (M mode When the system is in M mode, you can magnify a portion of
only) the reference image using M mode zoom function.

49
3-2-4-2 CF mode checks

Table 3-3 Color flow (CF) mode


Imaging optimization Functions
controls
Gain Gain amplifies the overall strength of echoes processed
in the Color Flow window or spectral Doppler timeline.

Pulse Repetition Increase or decrease the PRF.


Frequency (PRF)
Threshold Threshold assigns the gray scale level at which color
information stops.

Baseline Changes the Color Flow or Doppler spectrum baseline to


accommodate higher velocity blood flow.

Wall Filter It helps get rid of motion artifacts caused from breathing
and other patient motion by filtering out the low velocity
signals.

Color Map To select a specific color map, activate Color Flow first,
and then select Map from the Color Flow Top/Sub menu.

Invert (Color Invert) To reverse the color flow, press Invert (Color Invert).

50
3-2-4-3 PWD mode checks

Table 3-4 Pulsed wave doppler (PWD) mode


Imaging optimization Functions
controls
Doppler Sample Adjust the sample volume gate size.
Volume Length
PRF Adjust the velocity scale to accommodate
faster/slower blood flow velocities. Velocity scale
determines pulse repetition frequency.

Baseline Adjust the baseline to accommodate faster or


slower blood flows to eliminate aliasing.

Wall Filter Insulate the Doppler signal from excessive noise


caused from vessel movement.
Angle Correct Estimate the flow velocity in a direction at an angle
to the Doppler vector by computing the angle
between the Doppler vector and the flow to be
measured.

Invert Vertically invert the spectral trace without affecting


the baseline position.

3-2-5 Basic measurements function checks


To begin the measurement, follow these steps:

1. On the control panel, press the Measure key on the control panel.

2. Use Trackball to move the point.

3. Press the Set key to fix the point.

51
3-2-5-1 Distance

4. Press Distance on the Soft key menu. The start point is displayed.

5. Move the marker to the start point using Trackball.

6. To fix the point, press the Set key. The end point, overlapping the start point, appears.

7. Move the marker to the end point using Trackball, and then press the Set key.

8. The measure value is fixed.

3-2-5-2 Ellipse

9. Press Ellipse on the Soft key menu. The start point is displayed.

10. Move the marker to the start point using Trackball, and then press the Set key.

11. The first point is fixed and the second point appears.

12. Move the marker to the second point using Trackball. The ellipse appears.

13. Press the Set key. The end point appears.

14. Move the marker to the second point using Trackball, and then press the Set key again.

15. The measure value is fixed.

52
3-2-5-3 Trace

16. Press Trace on the Soft key menu. The start point is displayed.

17. Move the marker to the start point using Trackball, and then press the Set key.

18. The end point appears.

19. Move the end point gradually along the circumference of the target object using Trackball.

20. Press the Set key. The end point appears.

21. The start point and the end point are connected with a line and they are automatically
close the trace.

22. The measure value is fixed.

3-2-5-4 Slope

23. Press Slope on the Soft key menu. The vertical line and the horizontal line are displayed
perpendicular to each other.

24. Use Trackball to move the point where they intersection point, and then press the Set key.

25. The start point is fixed and the end point appears.

26. Use Trackball to move the point, and then press the Set key again.

27. The oblique line is displayed and the slope is calculated.

53
3-2-5-5 Time

28. Press Time on the Soft key menu. The vertical line and the horizontal line are displayed
perpendicular to each other.

29. Use Trackball to move the point where they intersection point, and then press the Set
key.

30. The start point is fixed and the end point appears.

31. Use Trackball to move the point, and then press the Set key again.

32. The time interval between the two points is displayed.

3-2-5-6 Velocity

33. Press Velocity on the Soft key menu. The vertical line and the horizontal line are
displayed perpendicular to each other.

34. Use Trackball to move the point where they intersection point, and then press the Set
key.

35. The measure value is fixed.

3-2-6 CINE Imaging Function Checks


Cinegate image review is the storage and review of a sequence of images in system memory.
Cinegate review is available by pressing the Freeze key. Moving Trackball left to right
moves through the Cinegate sequence. Image from a Cinegate sequences can be measured
and annotated.

To activate CINE,
1. Press Freeze.
2. Use Trackball to move through the Cinegate sequence frame-by-frame.
3. Select move first frame (Soft menu key) to take first frame.
4. Select move last frame (Soft menu key) to take last frame.
5. To exit the Cinegate, press the Freeze or 2D key on the control panel.

54
3-2-7 Transducer connectors function checks
3-2-7-1 Activating the transducer

Use the following procedure to activate the transducer and application.

1. On the control panel, press the Transducer key.


2. The Transducer and Application Selection dialog box appears.
3. All connected transducers and activated one are highlighted. Shows all
applications for the active transducer. Shows all presets for the application.
4. Move the cursor to select the desired transducer, application and preset using
Trackball on the control panel. Press the Set key on the control panel.
NOTE: Default transducer for the selected preset or default preset for selected
transducer is selected automatically.

5. Click Exit on the Transducer and Application Selection dialog box to save your
selections and exit the Transducer and Application Selection dialog box.
NOTE: If enabled “Exit window when transducer selected”, will exit the transducer
and application selection window when transducer selected.

3-2-7-2 Deactivating the transducer

NOTE: Before deactivating the transducer, press the Freeze key on the control panel.
An error may occur when you deactivate the transducer while running it.

Use the following procedure to deactivate the transducer.

1. Press the Freeze key on the control panel.


2. Clean the gel from the transducer.
3. Gently wipe the excess gel from the face of the transducer.
4. Place the transducer in its holder.

55
3-2-8 DVR function checks
To select the DVR,

1. Select the System preset > System > Peripherals.


2. Select the DVR recorder from the dropdown list.
3. Click Save and Exit.
4. Press the DVR key on the control panel. Soft key menu for DVR control appears.

Figure 3-3 Peripheral

56
To record an image,

NOTE: Before recording, make sure that the DVD recorder power is on and the media is
played in the tray.
1. Insert a media into the recorder.
2. Press REC on the softkey menu.

To pause recording, you press PAUSE on the softkey menu.

To start recording again, press REC on the softkey menu on more time.

To stop recording, press STOP on the softkey menu.

NOTE: You can use footswitch or the Print key on the control panel to record or pause.
For more detail configuration, go to System Preset > User Setting > Print / Foot switch.

3-2-9 Backup and restore function checks


The Back up/Restore preset allows you to back up and restore the user data. The
following submenus are available:

 User Backup
 Image Backup
 Full Backup

Depending on the system, you can select a CD, DVD, or USB flash drive.
To perform the full backup, you can use an external USB type of hard disk drive. Depending
on the external USB memory, some types may not be supported.

57
3-2-9-1 User Backup

NOTE: A CD, DVD, and USB flash drive are available for user preset backup.

Figure 3-4 User Backup

User preset allows you to back up the each preset data. To select all user-defined presets,
select the User Defined Configuration check box.

 Image Preset: Set to back up or restore the Image preset only.


 Service: Set to back up or restore the Service preset only.
 Measurement: Set to back up or restore the Measurement preset only.
 Annotation: Set to back up or restore the Text and Body Pattern preset only.
 Connectivity: Set to back up or restore the Connectivity preset only.
 Others: Set to back up or restore other presets such as System and User settings.

58
To back up the user preset data,

36. Select a media.

37. Insert a blank media properly on your system.

38. Select the user preset you want to back up.

39. Click Backup to start backup. The backup procedure begins.

40. After the backup is completed, the last backup time and date appears next to the preset
category.

To restore the user preset data,

NOTE: Make sure that the software version of the data is the same as the system’s software
version. If NOT, you may not perform restoration.

41. Insert a media on your system.

42. Select the user preset(s) you want to restore.

43. Click Restore to start restoring. The restore procedure begins.

59
3-2-9-2 Image Backup

NOTE: A CD, DVD, and USB hard disk are available for Image Archive.

CAUTION
 While restoring Image Archive data, some existing database may be overwritten on the
local hard disk and you may not be able to restore the old data. Make sure that you use
the appropriate media before the restoration proceeds.
 Before restoring Image Archive, make sure that the software version is the same or
compatible with. The system may not proceed restoring if the version is different.
 Do NOT turn the system off while backup is in progress. You may lose your image data.

NOTE: Use Import on Patient Browser to restore image data.

Figure 3-5 Image Backup

Media
 Media: Select your media, CD or DVD.
 Media Capacity: Select the media capacity. The system calculates the number of
backup CDs before performing backup and informing you.

60
Backup, Export Setting
 Backup files older than in days: Specify the number of days to perform backup. When
you select Today, system back up all patient and image data.
 Image move after backup: Set to remove the backup image file after backup is
completed.
 Verification after the finalization (Backup): Verify all files after finalization when you
backup.
 Verification after the finalization (Export): Verify all files after finalization when you
export image data.
 Generate DICOM Dir file when export: Set the system generates a DICOM Dir file
when you export data.

NOTE: DICOM Dir is a DICOM file format which provides index and summary information
for all the DICOM files on media. If you want to save studies to CD or DVD and view them
on the PACS system, you should select this option.

To back up Image Archive,

44. Configure Image Archive.

45. Prepare unformatted CD(s).

46. Click Backup to start backup Image archive.

47. The media formatting starts and the instructional message appears. You can view and
import backed up media via Patient Browser and Patient menu.

To view the backup images,

48. Insert your media.

49. Go to Patient or Patient browser.

50. Change the source to CD or DVD from the local hard disk.

51. View the backup images of the study you want.

61
3-2-9-3 Full Backup

NOTE: Only the USB HDD is available for the full preset backup.

The full preset backup is only for service purpose. You can back up the system data such as
User preset, Image Archive, and Service configuration.

Figure 3-6 Full Backup

62
3-3 Monitor Functions
Verify the monitor functions by performing the following procedure.

To configure in the System Preset menu,

52. Press the System Preset key on the control panel.

53. From the Monitor category, check the resolution, gray bar, and color bar settings.

Figure 3-7 Monitor function checks

63
To configure on the monitor,

54. Press the Mode/Select button at the right side of the monitor once.

55. Adjust the contrast, brightness, or dim brightness value using the Up (∧) or Down (∨) button.
The value appears on the screen.

Figure 3-8 Monitor function checks

1. Up (∧) button
2. Mode/Select (◇)button
3. Down (∨) button
4. LED lamp button
5. LED lamp

CAUTION: The LED lamp may overheat. Be careful not to directly touch it to avoid injury.

64
3-4 Mechanical Functions
3-4-1 Cover parts functions
The following list shows cover parts of the field-replaceable unit (FRU).
No Item
1 VNS Body Front Cover
2 VNS Body Side Cover R
3 VNS Body Side Cover L
4 VNS Body Top Cover
5 VNS Body Top Rear Cover
6 VNS Body Rear Cover
7 Cable Holder

1. Check if the FRU parts are assembled tightly by naked eye and hands.
2. Check if there are dents, scratches or cracks on the FRU parts.
3. Check if all of the screws are in place.

3-4-2 Air filter function checks


Check if the air filter is installed securely.

.
Figure 3-9 Air filter function checks

3-4-3 Knob function checks


1. Check if the each button operates properly.

2. Check if encoder knobs are in the center.

3. Check if the keycap set cannot be removed easily.

65
Figure 3-10 Button and knob function checks

3-4-4 Front & Rear caster function checks


1. For the bi break caster, check all caster locks and caster swivel locks for proper operation.
2. Check if the front caster locks operates properly.
3. Check if the rear caster operates properly.
4. Check if all screws are in place.

Figure 3-11 Cast checks

66
3-4-5 Transducer holder checks
Check if the transducer holder is not removed easily with your touch.

Figure 3-12 Transducer holder checks

3-4-6 Standard arm function checks


1. Check if the standard arm operates properly (rotating and tilting)
2. Check if the cover parts of the standard arm cannot be removed easily.
3. Check if the lock operates properly.

Folded Tilt fowrard Default posture Tilt backward

Default posture
Left-side rotating Right-side rotating

Figure 3-13 Standard arm function check

67
3-5 Board Functions

3-5-1 Board function checks

WARNING: When Service Login for FRU Diagnostic, scan mode must be B-Mode. After
Diagnostic is completed the system should be rebooted. Diagnostic should be performed
with transducers.

Figure 3-14 Diagnostic test

56. Press the Power On/Off key to turn on the system.

57. Log in as a service account. Refer to 4-3 Service Platform.

58. Select Diagnostics > Hardware > Overall.

59. Start a diagnostic test.

60. When all items for the diagnostic test are successfully passed, shut down the system.

61. Reboot the system.

62. Check the basic functions in each mode.

68
Chapter 4. Components and Functions
This chapter provides a system’s block diagram, main functional segments, and service
platform to describe main components and functions.

 General Information

 Block Diagram

 Segment Functional Descriptions

 Service Platform

69
4-1 General Information
E-CUBE 7 is a medical ultrasound system that is used for the following modes:

- B Mode
- M Mode
- Color Flow(CF) Mode
- Tissue Doppler(TD) Mode
- Power Doppler Mode
- Pulsed Wave(PW) Doppler Mode with High PRF
- Different combination of the above modes

The main functional segments of the E-CUBE 7 platform are listed and described as
follows:

- Transducer Interface(TI) Segment


- Front End (FE) Segment
- INOUT(IO) Segment
- Power Supply Unit (PSU) Segment
- Keyboard and Control Panel Segment
- Peripherals

70
4-2 Block Diagram
4-2-1 E-CUBE 7 functional block diagram
Figure4-1 describes a block diagram of E-CUBE 7. E-CUBE 7 consists of the main functional
segments as follows:

TI board BP FE board IO board

I2C
I2C to GPIO
LAN
FPGA
IDPROM IDPROM SATA
Pulser
64 (STHV748) HDD
Pulser
Port A Pulse (STHV748)
Pulser
Pulser Control

128 out (STHV748)


VGA

128 DSP
Relay HV-MUX (DM642) PC
block (HV2701) emif i/f (Com-express) S-Video
Converter

Port B
AFE5808
128 AFE5808 PCI USB
AFE5808 LVDS Beamformer Digital Receiver
VCA ADC
PCIe Audio
PCI Bridge CODEC
(PEX8111)

I2C
RF & Pulse
IDPROM

Figure4-1 E-CUBE 7 Functional block diagram

71
4-3 Segment Functional Descriptions
4-3-1 Transducer Interface (TI) segment
The E-CUBE 7 Transducer Interface (TI) includes the following boards:

TI board: Enables acquisition of signals from and to probes


TI board performs the following functions
- Transmit/Receive switching
- Transducer interface

Figure4-2 shows the TI board detailed block diagram.

I2C
GPIO I2C to GPIO
I2Cconverter
to GPIO
converter

Relay Driver

128
element IDPROM
Port A
(DLP connector)

HV-MUX
(HV2701)
Relay
block

(64EA)

128
Port B element
(DLP connector)

Figure4-2 TI board block diagram

HV_MUX

Max Xd elements Max System channels


E-cube7 1.0 Up to 128 elements 64 channels
E-cube7 2.0 Up to 192 elements 64 channels
Table 4-1

Transducer Connector

E-cube7 1.0: 2 Xd connectors


E-cube7 2.0: 3 Xd connectors

72
4-3-2 Front End (FE) segment
The E-CUBE 7 FE segment includes the following boards:

- FE64 board: FE64 board has 64 transmit/receive channels.

I2C

FPGA
IDPROM
Pulser
(STHV748)
Pulser Pulser Control
(STHV748)
Pulser
(STHV748)

DSP
(DM642)
emif i/f

AFE5808
AFE5808 PCI
AFE5808 LVDS Beamformer Digital Receiver
VCA ADC
PCIe
PCI Bridge
(PEX8111)

Figure4-3 E-CUBE 7 FE board block diagram

FE board
FE board performs the following functions:

- Receive beam forming


- 64Channel High-voltage transmits Pulse generation
- 64Channel Transmit/Receive Switching
- Receive analog signal gain control
- Receive Signal digitization
-

73
TX/RX Module
Overview
TX/RX Module includes the following boards
 Pre-Amplifier
- Input impedance: 4.5 KOhm
- Input signal range: 0.25/0.5/1.0 Vpp
- Gain: 24/18/12 dB
 TGC
- Gain range: 46dB
- Output signal range: Max 1.0V/SE
- Gain control signal: 0 to 1.5V
 Anti-aliasing LPF
- Cutoff frequency: 10MHz or 15MHz
 Sample rate: Up to 65 MSPS
 Resolution: 12 bits
 Input range: 2.03Vpp
 SNR: 61.7 dBFS SNR at 5MHz

• Pulser
 Pulse Voltage: 0 ~ ± 80 Vpp
 Transmit Apodization: disable
 Pulse Duration: variable
 Frequency: Up to 15MHz
 Damp/Clamp: enable

Conventional Dynamic Receive Beamforming


Beamforming performs 64Channel Beamforming. main Specification are as follows.
 Receive Beamforming Frequency : 40MHz
 Maximum Receive Beamforming Depth : 30cm
 Dynamic Aperture
 Dynamic Apodization
 Multibeam Receive Beamforming

74
4-3-3 IO Segment
The E-CUBE 7 IO includes the following Modules.
- Real-time Control
- PC Interface
- Clock Generator

IO board

LAN

SATA
HDD

VGA

PC
(Com-express) S-Video
Converter

USB

PCIe Audio
CODEC

I2C

IDPROM

Figure 4-4 IO Block Diagram

The main functional segments of IO board are as follow.

- System Master Clock generator

- Real-time control

- B/M/D/C signal processing

- System BUS Master connected to each board

- PC based Application processing, external In/Out Interface supported

75
4-3-4 COM Express PC Segment
COM Express PC performs the following functions.
- Real time control of ultrasound imaging system hardware
- UI input interpretation and response
- Measurements and reports
- DICOM image storage, archival, retrieval and manipulation
- Keyboard and control panel interfaces
- External in/out Interface for peripheral Device
COM Express Module’s main specification are as following.
- Processor : Intel Core 2 Duo 2.26GHz
- Memory : 2 sockets(DDR3 1066MHz, 1GBx2)
- Chipset
- Graphics and Memory Controller Hub(GMCH) Intel GM45
- Intel I/O Controller Hub 82801IEM (ICH9M-E)

IO/IOSUB

COM express Base


Board SATA
HDD
USB
Peripheral
Ethernet
Transformer RJ45 Con

DVI ch.1
SDVO Main Monitor
SDVO DVI DVI
To
Splitter DVI ch.2
DVI Sub Monitor

VGA(RGB)
Sub Monitor

Video Y, C, Composite
Converter Peripheral

LPC BUS

Audio Out
Audio Signals Audio AMP
Audio
Codec Audio IN
PCI express
Bus RCA Jack

Figure 4-5 COM express and IO board Block Diagram

4-3-5 Power Supply Unit (PSU)


+
The Power Supply Unit (PSU) provides the Vix000 platform with both low voltage and high voltage power,
and also enables recharging of the battery.

4-3-6 Keyboard and Control Panel


The control panel of the E-CUBE 7 consists of the QWERTY keyboard, Trackball, Encode 0,
soft keys, and USB Interface Module.
- Main board: QWERTY keyboard, Trackball, Encoder, Soft key and USB Interface
module
- Soft board: Encoder 1

- DGC board: TGC slide controls

76
4-3-7 Peripherals
E-CUBE 7 support the following peripheral
- Digital BW printer
- Digital Color printer
- Analog BW printer
- Analog Color printer
- DVD recorder
- DVD R/W
- Foot switch
- External Monitor(DVI, VGA)

E-CUBE 7 consists of IO interface that can connect peripheral. IO, IOSUB Board include a connector for.
IO, Input and output signal for peripheral support in IOSUB Board are as following
- Ethernet
 10/100 Mbps
- USB Port
 USB2.0, 10 EA, Digital BW printer, Digital color printer, DVD R/W, DVD recorder, Foot S/W,
Control Panel
- VGA
 External VGA monitor
- DVI
 Main DVI monitor, External DVI monitor
- S-video in/out
 DVD recorder의 video Signal
- Composite out
 Analog color printer 1 EA
- Y out
 Analog BW printer 2 EA
- Printer shutter
 Analog printer의 shutter input
- Audio
Main speaker, DVD recorder’s audio Signal Support.

77
4-3-8 Monitor

The E-CUBE 7 system has a 19 inch LCD monitor with DVI-HDMI interface. The monitor also
has a task lamp to light up the A/N key on CP assy.
The monitor of E-CUBE 7 have completely same function and same hardware assembly.
AR coating is applied to the monitor filter.

Figure4-6 E-CUBE 7 monitor

4-3-8-1 Monitor signal I/O


The Monitor Assy has three main I/O connectors: One is for DVI-HDMI connection to scan
and show an image, 24V power supply, and the other is for speaker.

POWER
HDMI

Speaker L
Speaker R

Figure4-7 E-CUBE 7 Monitor signal I/O

78
Table 4-2 HDMI connector PIN MAP
PIN # PIN NAME IO BOARD Remarks
P1 DVI1_TX2+ DVI Video
P2 GND Shield
P3 DVI1_TX2- DVI Video
P4 DVI1_TX1+ DVI Video
P5 GND Shield
P6 DVI1_TX1- DVI Video
P7 DVI1_TX0+ DVI Video
P8 GND Shield
P9 DVI1 TX0- DVI Video
P10 DVI1 TXC+ DVI Video
P11 GND Shield
P12 DVI1 TXC- DVI Video
P13 RS232_RXD RS232_TXD
P14 RS232_TXD RS232_RXD
P15 DDC_CLK IO MONITOR DDC Clock
P16 DDC_DATA IO MONITOR DDC data
P17 Reserved NC
P18 D5V_DVI +5V
P19 DVI1_HTPLG Hot plug

4-3-9 QWERTY keyboard and control panel

The control panel of the E-CUBE 7 consists of the QWERTY keyboard, Trackball, Encode 0,
soft keys, and USB Interface Module.
- Main board: QWERTY keyboard, Trackball, Encoder, Soft key and USB Interface
module
- Soft board: Encoder 1

- DGC board: TGC slide controls

The main board of the control panel is as following:

Figure4-8 CP Assy

79
4-3-10 I/O panel

E-CUBE 7 system has the I/O interface that is connected to the peripheral. The I/O panel is
included in connector for the peripheral. Y out and Composite out are analog video interface for
B/W printer and color printer. The printer shutter is an interface that controls the display and
print keys.
S-Video In/Out is an analog video interface that controls playback and recording of the DVD
recorder and analog color printer. Audio In/Out is an audio interface that controls audio
playback and audio recording of the DVD recorder. The I/O panel has four extended USB ports
for USB hub device. VGA and DVI signal is display interface for an external monitor.

Composite out(Color)
Printer shutter(Color)
Printer shutter(BW)

VGA video out

USB from hub


DVI video out
S-video out

S-video in
Y out(BW)
Audio out

Ethernet
Audio in

Connector

Figure 4-9 E-CUBE 7 I/O panel signal

80
Table 4-3 Input/Output signals for peripherals
Signal name Description Connection from/via/to
Ethernet Standard TCP/IP Syscon -> I/O penal ->
Ethernet LAN Connector
USB Port for Digital BW USB Port for Digital I/O panel (USB hub) ->
printer BW printer USB connector(A-type) -
> Digital BW printer
USB Port for Digital Color USB Port for Digital I/O panel (USB hub) ->
printer Color printer USB connector(A-type) -
> Digital Color printer
USB port for Foot Switch USB port for Foot Foot switch -> USB
Switch connector(A-type) ->
Syscon
USB port for Digital DVD USB port for Digital I/O panel (USB hub) ->
Recorder DVD Recorder USB connector(A-type) -
> Digital DVD recorder
printer
External VGA VGA signal output for Syscon -> I/O penal ->
external VGA monitor D-sub connector
External DVI DVI signal output for Syscon -> I/O penal ->
external DVI monitor DVI connector
S-video in for DVD S-video input signal for S-video connector -> I/O
Recorder and Analog Analog DVD Recorder penal -> Syscon
Color printer and Analog Color
printer
S-video in for DVD S-video output signal Syscon -> I/O penal ->
Recorder and Analog for Analog DVD S-video connector
Color printer Recorder and Analog
Color printer
Composite out for Analog Composite video signal Syscon -> I/O penal ->
Color printer output for Analog Color BNC
printer
Composite out for Analog Composite video signal Syscon -> I/O penal ->
BW printer output for Analog BW BNC
printer
Printer shutter(Analog Printer shutter of Syscon -> I/O penal ->
Color printer) Analog Color printer for Audio jack
printing screen of
system
Printer shutter(Analog BW Printer shutter of Syscon -> I/O penal ->
printer) Analog Color printer to Audio jack
printing screen of
system
Audio in for Analog DVD Audio input signal for RCA jack -> IO penal ->
recorder Analog DVD Recorder Syscon
Audio out for Analog DVD Audio output signal for Syscon -> I/O penal ->
recorder Analog DVD Recorder RCA jack

81
4-3-11 Power diagram

4-3-11-1 Overview

The power module main task is supplying power to various internal subsystems (system,
AC fan, monitor, outlet). The voltage to peripherals can be confederated to either 110 VAC
or 220 VAC. Input voltage is one adapter-all voltage.

4-3-11-2 Power Module

Figure4-10 E-CUBE7 power block diagram

4-3-11-3 DC output specification

To turn on the DC output voltage, the live power is needed as a standby power. This live power is
generated from power module. When the live power is supplied to the BE board and system
momentary switch is pushed on, BE board switches the PS_ON signal to low level to turn on DC
output voltage.
DC output capacity
- A4.2VP, 3.6A rms
- A7VP, 0.3A rms
- A5VN, 0.3A rms
- A12VP, 10A rms
- A12VN, 2A rms
- D3.3VP, 9.5A rms
- D5VP, 7.1A rms
- P5D_STB, 0.4A rms

Power module supplies High-voltage power to activate high voltage transmit pulse and static
supply bias voltage on high voltage HVMUX. When BE Board makes the HV_STOP signal to low,
power module generates the high voltage. The power module supplies +/-100V to the system
82
constantly and the VHVP and VHVN supplies 0~+/-80V individually.
BE Board controls the level of VHVP and VHVN through the IIC interface.
HV output capacity
- FHVP, 0.005A rms
- FHVN, 0.005A rms
- VHVP1, 0.2A rms
- VHVN1, 0.2A rms
- VHVP2, 0.2A rms
- VHVN2, 0.2A rms

83
4-3-12 Air filter
1.. Pull out the knob inside the air filter

PUSH

.
Figure 4-11 Air filter

84
4-4 Service Platform
The Service platform contains a set of software modules for the diagnostic each modules.

4-4-1 Service login


1. Press the System Preset key on the control panel.
2. Click Administration.
3. Click Service Station on the Service tab.

Figure 4-12 Service Station

4. The service login window for Service Platform appears on the display.

Figure 4-13 Login screen

85
4-4-2 Access & Security
The service interface has different access and security account levels. Each account is only
permitted to access the tools that are authorized for their use. For an ALPINION field engineer,
changing the password may be required at regular intervals.

To log in as each account,

 Operator: User account; the password is “alp.”

 Partner: Dealer account; It will be change the password every 3 month.

 Engineer: Engineer account; It will be change the password every 3 month.

 Admin: Manufacturer account; It will be change the password every 3 month.

4-4-3 Service homepage


When the Service station starts, the service homepage appears.
The homepage contains the software revision along with the hardware inventory and the results of
the latest system information.

Figure 4-14 Service homepage

 Top menu: Top-level category

 Tree menu: the context menu of a top menu

 Main window: interaction area for the context menu

 Exit button: Exit the service station.

86
4-4-3-1 License management

License Management shows the status of licenses for optional features.


If you add a key for another system, it does not work even if the option related to the key is
not invalid.

Figure 4-15 License management

The available option status is as follows:


- Trial: 3-month-trial license is activated.
- Invalid: No license is available.
- Demo: The license is activated for a specified period.
- Permanent: The license is activated permanently.

87
4-4-3-2 Control panel

Click Control Panel Test. The test program appears.

Figure 4-16 Control panel test page

4-3-3-3 Monitor

Click Start. The test patterns appear.

Figure 4-17 Monitor test page

88
4-3-3-4 Audio

Check the audio sound for left and right speakers.

Figure 4-18 Audio test page

4-3-4 Utility
4-3-4-1 Disk surface scan

63. Click Open the disk scanner.

64. Click I Accept.

89
65. Check the target drive and select Long Drive Self Test.

66. When the test is completed, the drive status (Pass or Failed) appears.

NOTE:
 Do not touch any button until the test is completed.
 Do not run the Advanced tests and System Tools.

4-3-4-2 Windows Services

Windows Services shows all service lists. You can view all services that are currently
activated and deactivated.
To refresh the list, click Update. To show details for the selected service, click Look into.

90
Figure 4-19 Windows service page

91
4-3-5 Log viewer
The log viewer consists three categories: with ECUBE Log, ECUBE Event Log, and Window
Event Log. You can view all scanner logs by using the log viewer. The service Interface supports
the transfer of these logs to local destinations such as CD/DVD and USB.

Figure 4-20 Log viewer page

4-3-5-1 ECUBE Log

ECUBE Log consists six categories: Crash, Diagnostics, Control Panel, DICOM, Debug,
Overall. The log table has the following categories:

 Crash : Crash dump files

 Diagnostics: Diagnostics logs

 Control Panel: Key logs

 DICOM: DICOM logs

 Debug: Programmer’s logs

 Overall: All logs

92
Chapter 5. Replacing Components
This chapter provides you with procedures about replacing the each hardware component,
installing and restoring the system software.

 Disassembly and Reassembly

 System Software Loading Procedure

 Installing the Mechanical Options

93
5-1 Disassembly and Reassembly
This section describes how to disassemble and reassemble for the replacing the component. Keep
in mind that the only qualified service personnel should perform this.

WARNING
 To avoid accidental contact, be familiar with all hazardous voltages and high current levels.

 Do not disassemble any parts under the specified FRU unit.

CAUTION
Turn off the system and unplug the power cord before disassembling the power supply unit. Do not
wear an ESD wrist strap during the disassembly a part of power supply. However, when you
disassemble a circuit board, always wear the strap to prevent electric shock after the system
power is off.

General preparations
Prepare the following requirements before performing disassembly and reassembly.

 Required tools

- Common screwdrivers: Flat tip, cross tip


- Milli wrench

 Required manpower and time: Maximum of 2 persons and 2 hours for each component

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

NOTE: Depending on the component, the required tools, manpower, and time may be slightly
different.

94
5-1-1 PSU Fuse Assy
 Required manpower and time: 1 person, approximately 5 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Replace 2 fuses located on the PSU Outlet Assy.

Figure 5-1 Fuse on the PSU Outlet Assy

 Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

95
5-1-2 PSU Assy
 Required manpower and time: 2 persons, approximately 30 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Unscrew 4 screws (Left 2 screws and Right 2 screws at the bottom of the equipment) to
remove the PSU Assy.

Figure 5-2 Screws of PSU ASSY

2. Slide down the PSU Assy and put it down on the floor carefully.

Figure 5-3 Push direction of PSU Assy

96
3. Remove all connectors inside of PSU Assy.

Figure 5-4 Push direction of PSU Assy

 Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

97
5-1-3 Air Filter
 Required manpower and time: 1 person, approximately 5 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Slide the filter to arrow direction.

Figure 5-5 Pull direction of Air Filter

2. Separate the Air filter.

Figure 5-6 Air Filter

 Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

5-1-4 Control Panel (CP) Assy


 Required manpower and time: 1 person, approximately 20 minutes
98
 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Unscrew 3 screws on the bottom of the CP Assy.

Figure 5-7 Center screws of CP Assy

2. Unscrew 14 screws on the bottom of the CP Assy.

Figure 5-8 Screws of CP Assy

99
3. Life up the top cover of the CP Assy.

Figure 5-9 Lifting up the top cover

4. Disconnect 2 cables from the CP Assy.

Figure 5-10 Disconnecting 2 cables

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

100
5-1-5 AN Keyboard (QWERTY Keyboard) Assy
 Required manpower and time: 1 person, approximately 30 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the CP Assy. Refer to 5-1-4 CP Assy.

Figure 5-11 AN Keyboard Assy in CP Assy

2. Disconnect 2 cables.

Figure 5-12 Disconnecting 2 cables

101
3. Unscrew 7 screws and remove the bracket.

Figure 5-13 Screws and bracket of AN Keyboard Assy

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

102
5-1-6 DGC Knob Set & DGC Key Assy
 Required manpower and time: 1 person, approximately 30 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the CP Assy. Refer to 5-1-4 CP Assy.

2. Remove the DGC knobs.

Figure 5-14 Remove the DGC knobs

3. Remove 1 connector from the PCB.

Figure 5-15 DGC key connector

103
4. Unscrew 4 screws.

Figure 5-16 Screws of DGC Key Assy

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

104
5-1-7 Trackball Assy
 Required manpower and time: 1 person, approximately 30 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the CP Assy. Refer to 5-1-4 CP Assy.

2. Unscrew 4 screws.

Figure 5-17 Screws for Trackball bracket

3. Remove 1 connector from the PCB.

Figure 5-18 Connector for Trackball

105
4. Unscrew 2 screws.

Figure 5-19 Screws for Trackball

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

106
5-1-8 Single Knob Assy
 Required manpower and time: 1 person, approximately 5 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

Remove all single knobs from the CP Assy.

Figure 5-20 Single knobs in CP Assy

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

107
5-1-9 Main PCB Assy
 Required manpower and time: 1 person, approximately 40 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the CP Assy. Refer to 5-1-4 CP Assy.

2. Remove the Single Knob Assy from the CP Assy. Refer to 5-1-8.

3. Remove the Trackball bracket from the CP Assy. Refer to 5-1-7.

4. Remove 4 connectors from the PCB.

Figure 5-21 Connector for Main PCB Assy

108
5. Unscrew 36 screws.

Figure 5-22 Screws for Main PCB Assy

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

109
5-1-10 Power switch PCB Assy
 Required manpower and time: 1 person, approximately 30 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the CP Assy. Refer to 5-1-4 CP Assy.

2. Remove the Single Knob Assy from the CP Assy. Refer to 5-1-8.

3. Remove 1 connector from the PCB.

Figure 5-23 Connector for Power switch PCB Assy

4. Unscrew 6 screws.

Figure 5-24 Screw for Power switch PCB Assy

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

110
5-1-11 Rear & Left & Right body covers
 Required manpower and time: 1 person, approximately 10 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Unscrew 4 screws and remove the Rear cover.

Figure 5- 25 Rear body cover

111
2. Unscrew 4 screws and remove the left and right covers.

Figure 5- 26 Removing the body covers

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

112
5-1-12 Front body cover
 Required manpower and time: 1 person, approximately 20 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the rear and left and right covers of the system body. Refer to 5-1-11 Rear &
Left & Right body covers.

2. Unscrew 6 screws on the left and right side of the front cover.

Figure 5-27 Screws on the front cover

3. Remove the front cover from the system.

Figure 5-28 Front cover

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.
113
5-1-13 CP Cover Assy
 Required manpower and time: 1 person, approximately 40 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the CP Assy. Refer to 5-1-4 CP Assy.

2. Remove the AN Keyboard Assy. Refer to 5-1-5 AN Keyboard (QWERTY Keyboard)


Assy.

3. Remove the DGC Knob Assy. Refer to 5-1-6 DGC Knob Set & DGC Key Assy.

4. Remove the Trackball Assy. Refer to 5-1-7 Trackball Assy.

5. Remove the Single Knob Assy. Refer to 5-1-8 Single Knob Assy.

6. Remove the Main PCB Assy. Refer to 5-1-9 Main PCB Assy.

7. Remove the Power switch PCB Assy. Refer to 5-1-10 Power switch PCB Assy

Figure 5-29 CP Cover Assy

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

114
5-1-14 Cable Holder Assy
 Required manpower and time: 1 person, approximately 5 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

Unscrew 2 screws on the bottom of the CP Assy.

Figure 5-30 Screws of Cable Holder Assy

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

115
5-1-15 TI Board Assy
 Required manpower and time: 1 person, approximately 40 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the right & rear body cover. Refer to 5-1-11 Rear & Left & Right body covers.

2. Unscrew 14 screws and remove the right side EM cage cover.

Figure 5-31 Screws of right side EM cage cover

3. Unscrew 10 screws and remove the EM cage cover.

116
Figure 5-32 Screws of Rear side EM cage cover

4. Remove the TI Board Assy.

Figure 5-33 TI board Assy

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

117
5-1-16 FE Board Assy
 Required manpower and time: 1 person, approximately 20 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the rear body cover. Refer to 5-1-11 Rear & Left & Right body covers.

2. Remove the EM cage cover. Refer to Figure 5-32.

3. Remove 2 connectors from the IO board Assy.

Figure 5-34 Connectors on TI board ASSY

118
4. Remove the FE Board Assy.

Figure 5-35 FE board Assy

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

119
5-1-17 HDD Assy
 Required manpower and time: 1 person, approximately 20 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the left body cover. Refer to 5-1-11 Rear & Left & Right body covers.

2. Unscrew 4 screws.

Figure 5-36 Screws of the HDD bracket

3. Disconnect the SATA cable and SATA power cable from the backplane.

Figure 5-37 Removing the HDD cable

120
• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

121
5-1-18 IO Assy
 Required manpower and time: 1 person, approximately 40 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the rear body cover. Refer to 5-1-11 Rear & Left & Right body covers.

2. Remove the left & right body cover. Refer to 5-1-11 Rear & Left & Right body covers

3. Unscrew 6 screws and remove the HDD base bracket.

Figure 5-38 Screw of the HDD base bracket

122
4. Disconnect the IO cables.

Figure 5-39 IO cables

5. Unscrew 4 screws.

Figure 5-40 Unscrewing 4 screws

123
6. Remove the IO Assy.

Figure 5-41 Removing the IO Assy

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

124
5-1-19 IO Board Assy
 Required manpower and time: 1 person, approximately 1 hour

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the rear body cover. Refer to 5-1-11 Rear & Left & Right body covers.

2. Remove the left & right body cover. Refer to 5-1-11 Rear & Left & Right body covers

3. Remove the IO Assy. Refer to 5-1-18 IO Assy

4. Unscrew 17 screws and remove cover.

Figure 5-42 Screws of the IO Assy cover

125
5. Unscrew 5 screws.

Figure 5-43 Screw of the IO Board Assy

6. Remove IO Board Assy bracket.

Figure 5-44 IO Board Assy

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

126
5-1-20 COM Express Board Assy
 Required manpower and time: 1 person, approximately 1 hour

System preparation: When the system power is off, turn off the System
On/Off switch on the bottom rear of the system.
 Disassembly procedure

1. Remove the rear body cover. Refer to 5-1-11 Rear & Left & Right body covers.

2. Remove the left & right body cover. Refer to 5-1-11 Rear & Left & Right body covers

3. Remove the IO Assy. Refer to 5-1-18 IO Assy

4. Remove the IO Board Assy. Refer to 5-1-19 IO Board Assy

5. Remove the cable connector.

Figure 5-45 Disconnecting the COM Express cable

127
6. Unscrew 5 screws on the IO board Assy and separate COM Express Board Assy.

Figure 5-46 Unscrewing 6 screws on the BE board

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

128
5-1-21 BP Board Assy
 Required manpower and time: 1 person, approximately 1 hour and 30 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the FEBE Assy. Refer to 5-1-36 FEBE Assy.

2. Remove the rear body cover. Refer to 5-1-11 Rear & Left & Right body cover.

3. Remove the left & right body cover. Refer to 5-1-11 Rear & Left & Right body covers

4. Remove the TI Board Assy. Refer to 5-1-15 TI Board Assy

5. Remove the FE Board Assy. Refer to 5-1-15 FE Board Assy

6. Remove the IO Assy. Refer to 5-1-18 IO Assy

7. Disconnect 2 cables

Figure 5-47 Disconnecting cables

129
8. Unscrew 5 screws.

Figure 5-48 Unscrewing 5 screws

9. Separate TIFE Assy and Unscrew 9 screws.

130
Figure 5-49 TIFE Assy and 9 screws

10. Separate BP Board Assy.

Figure 5-50 BP Board Assy

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

131
5-1-22 LC Arm Cover Set
 Required manpower and time: 1 person, approximately 10 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Unscrew 1 screw, and push the knob and rotate it counter-clockwise to unlock the
standard arm.

Figure 5-51 Screws of Knob Locking

2. Unscrew 2 screws of the standard arm cover.

132
Figure 5-52 Screws of Knob Locking

• Reassembly procedure

Change the new parts and reassemble them in reverse order of disassembly.

133
5-1-23 Monitor Assy
 Required manpower and time: 2 persons, approximately 20 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Unscrew 2 screws and remove the hinge cover.

Figure 5-53 Unscrewing 2 screws

2. Disconnect the cables.

HDMI POWER

Speaker R
Speaker L

Figure 5-54 Disconnecting the cables

134
3. Unscrew 4 screws.

Figure 5-55 Unscrewing 4 screws from the neck

4. Separate the monitor from the monitor arm.

Figure 5-56 Separating the monitor

• Reassembly procedure

Change the new part and reassemble them in reverse order of disassembly.

135
5-1-24 Monitor cover set(19 inch)
 Required manpower and time: 1 person, approximately 40 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Unscrew 6 screws on the monitor hinge cover.

Figure 5-57 Unscrewing 6 screws

2. Open the Rear cover

136
Figure 5-58 Open the Cover

3. Remove the cables

137
Figure 5-59 Remove the cables

4. Remove the OSD and LAMP cables

Figure 5-60 Remove the OSD and LAMP cables

138
5. Open the cover

Figure 5-61 Open the Cover

139
5-1-25 LCD Open Frame Assy
 Required manpower and time: 2 persons, approximately 30 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the Monitor Assy. Refer to 5-1-37 Monitor Assy.

2. Unscrew 6 screws.

Figure 5-62 Screwing the Monitor Rear cover

3. Remove the 4 connector.

Figure 5-63 Disconnecting the cables

140
4. Unscrew 8 screws and remove the Monitor front Cover.

Figure 5-64 Screwing the Monitor Front cover

• Reassembly procedure

Change the new part and reassemble them in reverse order of disassembly.

141
5-1-26 Lamp Assy
 Required manpower and time: 2 person, approximately 30 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the Monitor Assy. Refer to 5-1-37 Monitor Assy.

2. Remove the Rear monitor cover. Refer to 5-1-38 LCD Open Frame Assy.

142
3. Disconnect the LAMP cable.

Figure 5-65 Disconnecting LAMP cable

4. Unscrew 1 screws of the lamp button module.

Figure 5-66 Screwing the LAMP ASSY

• Reassembly procedure

Change the new part and reassemble them in reverse order of disassembly.

143
5-1-27 OSD Button Assy
 Required manpower and time: 1 person, approximately 30 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the Monitor Assy. Refer to 5-1-37 Monitor Assy.

2. Remove the Rear monitor cover. Refer to 5-1-38 LCD Open Frame Assy.

3. Disconnect the OSD cable and Unscrew 2 screws.

Figure 5-67 Unscrewing 2 screws and OSD ASSY

• Reassembly procedure

Change the new part and reassemble them in reverse order of disassembly.

144
5-1-28 Speaker Assy
 Required manpower and time: 1 person, approximately 30 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the Monitor Assy. Refer to 5-1-37 Monitor Assy.

2. Remove the Rear monitor cover. Refer to 5-1-38 LCD Open Frame Assy.

3. Disconnect the speaker cable on the left and right side of the speaker.

Figure 5-68 Disconnecting the speaker cable

4. Unscrew 2 screws on each side of the speaker.

Figure 5-69 Unscrewing 2 screws

145
• Reassembly procedure

Change the new part and reassemble them in reverse order of disassembly.

146
5-1-29 DVD RW Assy
 Required manpower and time: 1 person, approximately 20 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

1. Remove the rear and left and right covers of the system body. Refer to 5-1-11 Rear &
Left & Right body covers.

2. Remove the frond body cover. Refer to 5-1-12 Front body cover

3. Unscrew 5 screws and remove the top body cover

Figure 5-70 Unscrewing 5 screws

4. Unscrew 4 screws.

Figure 5-71 Unscrewing 4 screws

147
5. Disconnect 2 cables

Figure 5-72 Disconnect 2 cables

6. Remove the DVD RW Assy

Figure 5-73 DVD RW Assy

 Reassembly procedure

Change the new part and reassemble them in reverse order of disassembly.

148
5-1-30 Standard Arm Assy
 Required manpower and time: 1 person, approximately 1 hour and 30 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

149
 Disassembly procedure

1. Remove the Monitor Assy. Refer to 5-1-38 Monitor Assy.

2. Unscrew 1 screw and remove the locking knob.

Figure 5-74 Unscrewing 1 screw

3. Unscrew 2 screws and remove the base cover.

Figure 5-75 Unscrewing 2 screws

150
4. Unscrew 2 screws.

Figure 5-76 Unscrewing 2 screws

5. Remove the cable tie and cable screen.

Figure 5-77 Removing cable tie and cable screen

6. Unscrew 4 screws.

Figure 5-78 Unscrewing 4 screws

151
7. Remove the cables.

Figure 5-79 Removing cables

 Reassembly procedure

Change the new part and reassemble them in reverse order of disassembly.

152
5-1-31 Bumper Assy
 Required manpower and time: 1 person, approximately 40 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

Unscrew 12 screws.

Figure 5-80 Unscrewing 12 screws

• Reassembly procedure

Change the new part and reassemble them in reverse order of disassembly.

153
5-1-47 Front & Rear Caster Assy
 Required manpower and time: 1 person, approximately 1 hour and 30 minutes

 System preparation: When the system power is off, turn off the System On/Off switch on
the bottom rear of the system.

 Disassembly procedure

Unscrew 16 screws.

Figure 5-81 Unscrewing 16 screws

• Reassembly procedure

Change the new part and reassemble them in reverse order of disassembly.

154
5-2 System Software Installation

5-2-1 Overview
This section describes the procedures how to install a new hard disk drive (Base system
software and Armstrong software) and update the software (application).

CAUTION:
Before starting the software loading, you must back up the patient image Data to the CD-R
or DVD.

To start installation, select one of the following options:

[A] Load the base system software and DELETE ALL patient and application
data.
- This option recovers system software including operation system and ERASES
ALL the system completely.

WARNING: All patient and application data will be removed permanently.


NOTE: Application software shall be installed after completion of this procedure.

[B] Load the base system software only.


- This option recovers the system software including operation system.

NOTE: Application software shall be installed after completing this procedure.

[C] Exit

5-2-2 Requirements
 Base System Software DVD (OS)

 Armstrong Software DVD (Application)

 Blank DVDs, CD-Rs or USB (for patient image or preset data backup)

155
5-2-3 Average installation time
The installation procedures may take about 1 hour. Make sure that this is based on an
experienced service engineer.

5-2-4 Preparations
5-2-4-1 Configuring the connectivity options

Before installation, you need to set the connectivity options in the System Preset menu.

1. Press the System Preset key on the control panel and go to Connectivity > General.

2. Set the following connectivity options:

- Computer Name, Device Name, Port No, IP Address, Subnet Mask, Default
Gateway, Network Speed

Figure 5-82 Connectivity options

156
5-2-5 Installing the software
5-2-5-1 Installing the base system software

This section describes the procedures about the software installation such as Base
System and Armstrong.

WARNING:
This installation may result in user data loss including patient and Application Data loss.
Please back up patient and application data before performing the installation.

NOTE:
All digital peripherals, reporting systems connected via the USB ports should be either
power off or disconnected network and remove all transducers prior to the software
installation.

1. Power the system on.

Figure 5-83 Startup screen

2. Press the DEL key until the following screen appears.

Figure 5-84 Boot-up screen

157
3. When the system asks for a password, enter “070427” and press the Enter key.

Figure 5-85 Password screen

4. When the setup screen appears, use the Enter and arrow keys to set the
following options:

 Boot Priority Selection: Typed Based


 1st Boot Device: Primary Master

Figure 5-86 Boot Device Priority

5. Insert the Base System Software Disk to the CD/DVD ROM drive.

158
6. From the Exit tab, select Save Changes > Exit and enter “OK.” The following
screen appears on the display.

Figure 5-87 Exiting configuration screen

7. After rebooting the system, the following screens appear as shown below.

159
Figure 5-88 Reboot screen

160
8. To start the installation, select one of the following options:

 [A] Load the base system software and DELETE ALL patient and
application data: Select this option to install a new HDD or format the
HDD. This option recovers the system software including operation
system and erases all the system completely.

 [B] Load the base system software only: Select this option to install
OS software only. This option recovers the system software including
operation system.

 [C] Exit: Cancel the installation.

Figure 5-89 Base system software

WARNING:
All patient and application data will be removed permanently.

NOTE:
Application software shall be installed after completion of this procedure.

161
9. After loading the base system software, the following screen appears.

Figure 5-90 Loading Base system software

10. Press any key to continue the installation. The following screen appears.

Figure 5-91 Finish loading the base system software

162
11. Press the C and Enter key. The following screen appears.

Figure 5-92 Select C & Enter

12. Eject the disk from the CD/DVD ROM drive.

Figure 5-93 Eject disk

13. When a pop-up window appears, enter “Exit” and press the Enter key. Then,
close the opened windows by selecting X. The system automatically reboots.

163
5-2-5-2 Configuring the base system software

1. Power the system on.

Figure 5-94 Startup screen

2. Press the DEL key until the following screen appears.

Figure 5-95 Boot-up screen

164
3. When the system asks for a password, enter “070427” and press the Enter key.

Figure 5-96 Password screen

4. When the setup screen appears, use the Enter and arrow keys to set the
following options:

 Boot Priority Selection: Typed Based


 1st Boot Device: Primary Master
 2nd Boot Device: USB CDROM

Figure 5-97 Boot Device Priority

165
5. To exit the configuration, press the Help key. You can also select Save
Changes > Exit in the Exit menu.

Figure 5-98 Save Changes and Exit

6. After rebooting the system, the following screen appears.

Figure 5-99 Startup screen

166
5-2-5-1 Installing the Armstrong software

1. Reboot the system. The desktop screen will be shown as below.

Figure 5-100 Desktop screen

2. Insert Armstrong CD and double-click the CD RAM DRIVE from My Computer.

Figure 5-101 CD RAM drive

3. Double-click the Armstrong installation icon.

Figure 5-102 Armstrong installation icon

4. Click Next.

167
Figure 5-103 Wizard Setup

5. Install the Armstrong software.

Figure 5-104 Installing the Armstrong

168
6. Select Yes, restart the computer now and click Finish.

Figure 5-105 Finish the installation

7. Windows is shutting down and the system automatically reboots.

Figure 5-106 Shutdown screen

169
8. Reboot the system and click My Computer > C:\Vi1000Gi\v1\RES\DB\Backup.

Figure 5-107 Desktop screen

9. Double-click RestoreDB.bat.

Figure 5-108 Desktop screen

170
10. The restoration starts and the following screen appears.

Figure 5-109 Restoring database

11. Double-click LogonManager inst & uninst on the desktop screen.

Figure 5-110 Logon manager

171
12. When a pop-up window appears, click Install.

Figure 5-111 Installation pop-up window

13. When the installation is completed, click OK.

Figure 5-112 Finishing the installation

172
14. When the shutdown window appears, click OK to restart the Windows.

Figure 5-113 System restart

15. The system automatically reboots.

Figure 5-114 System boot-up

173
16. After completing the system reboot, the default 2D mode screen appears.

Figure 5-115 2D mode screen

174
5-3 Finishing
67. After all peripherals have been installed, ensure that all cables are neatly and properly routed
to the system back and front panel. Use tie wraps, if necessary.

68. Properly store excess cable in the back panel cavity behind the door.

69. Fill out the proper customer information on the product locator card. Mail the installation card
“Product Locator” to the address corresponding to your region.

70. Properly dispose of any excess material in accordance with the system policy.

71. Once all peripherals have been installed, ensure that the operation of the system is verified
once again by performing the functional checks.

72. Ensure that each peripheral operates properly and then inform the customer of proper
peripheral operation.

73. Keep this documentation with this service manual for feature reference.

175
Chapter 6. Renewal Parts
This chapter provides you with renewal parts of E-CUBE 7.

• Power Supply Unit • Frame

• Air Filter • HDD

• Control Panel • IO

• Covers • Monitor

• TI/FE • Probe (Transducer)

• Cable

176
6-1 List of Renewal Parts
Table 6-1 Part List
Section P/N Part Name Q’ty FRU
CABLE 20002770 FRU-CABLE_BEIO_SATA_TO_HDD_SATA_7V10 1 1
CABLE 20002771 FRU-CABLE_BEIO_SATA_TO_FE_SATA_7V10 1 1
CABLE 20002772 FRU-CABLE_ACDC_PWR_TO_BEIO_PWR_7V10 1 1
CABLE 20002773 FRU-CABLE_ACDC_PWR_TO_BP_PWR22_7V10 1 1
CABLE 20002774 FRU-CABLE_ACDC_PWR_TO_BP_PWR24_7V10 1 1
CABLE 20002768 FRU-CABLE_BEIO_USB_TO_EXTERNAL_USB_7V10 1 1
CABLE 20002769 FRU-CABLE_BEIO_SATA_TO_DVD_RW_SATA_7V10 1 1
Control Panel 20002632 FRU-CP_ASSY FOR ECUBE-7 1 1
Control Panel 20002647 FRU-PCB SUB ASSY FOR ECUBE-7 1 1
Control Panel 20001666 FRU-DGC KNOB FOR ECUBE-7 1 1
Control Panel 20002645 FRU-PCB MAIN ASSY FOR ECUBE-7 1 1
Control Panel 20000276 FRU-DGC ASSY 1 1
Control Panel 20000128 FRU-KEYBOARDD ASSY 1 1
Control Panel 20000270 FRU-TRACKBALL ASSY 1 1
Control Panel 20002633 FRU-CP_COVER FOR ECUBE-7 1 1
COVERS 20002664 FRU-BODY_FRONT_COVER FOR ECUBE-7 1 1
COVERS 20002665 FRU-BODY_REAR_COVER_ASSY FOR ECUBE-7 1 1
COVERS 20002667 FRU-BODY_SIDE_COVER_R FOR ECUBE-7 1 1
COVERS 20002668 FRU-BODY_SIDE_COVER_L FOR ECUBE-7 1 1
COVERS 20002669 FRU-BODY_TOP_COVER FOR ECUBE-7 1 1
COVERS 20002670 FRU-BODY_TOP_REAR_COVER FOR ECUBE-7 1 1
FRAME 20002678 FRU-GEL_CUP FOR ECUBE-7 1 1
FRAME 20002679 FRU-PROBE_CUP FOR ECUBE-7 1 1
FRAME 20002680 FRU-PROBE_CUP_LARGE FOR ECUBE-7 1 1
FRAME 20002208 FRU-DVD_RW_SH-222AB 1 1
FRAME SVC00034 FRU-CASTER ASSY 1 1
FRAME SVC00037 FRU-LC ARM COVER SET 1 1
FRAME SVC00036 FRU-LC ARM ASSY 1 1
FRAME 20002009 FRU-AIR FILTER 1 1
HDD SVC00044 FRU-HDD ASSY FOR ECUBE-7 1 1
IO SVC00114 FRU-COMEXPRESS ASSY FOR ECUBE-7 1 1
IO SVC00109 FRU-IO BOARD ASSY FOR E-CUBE 7 1 1
MONITOR SVC00088 FRU-19 inch MONITOR ASSY 1 1
MONITOR SVC00087 FRU-19 inch LCD PANEL ASSY 1 1
MONITOR SVC00091 FRU-19 inch SPEAKER ASSY 1 1
MONITOR SVC00090 FRU-19 inch OSD BUTTON ASSY 1 1
MONITOR SVC00086 FRU-19 inch LAMP ASSY 1 1
POWER SVC00113 FRU-PSU_ASSY FOR E-CUBE 7 1 1
TIFE SVC00121 FRU-BP BOARD ASSY FOR E-CUBE 7 1 1
TIFE SVC00122 FRU-FE BOARD ASSY FOR E-CUBE 7 1 1
TIFE 20002652 FRU-80mm FAN 1 1
TIFE SVC00123 FRU-TI BOARD ASSY FOR E-CUBE 7 1 1
TIFE 20002961 FRU-TI BOARD ASSY V2.0 FOR E-CUBE 7 1 1
TIFE 20002648 FRU-TIFE_ASSY FOR E-CUBE 7 1 1
177
6-2 Power Supply Unit

Figure 6-1 Power Supply Unit

Item Part name Part number Q’ty Rev.1.0


1 FRU-PSU_ASSY FOR ECUBE7 SVC00113 1 Yes
Table 6-2 AC outlet

179
6-3 Air Filter

Figure 6-2 Air filter

Item Part name Part number Q’ty Rev. 1.0


2 FRU-AIR FILTER 20002009 1 Yes
Table 6-3 Air filter

180
6-4 Control Panel

5 10

4
8

9
7

Figure 6-3 Control panel

Item Part name Part number Q’ty Rev. 1.0


3 FRU-CP_ASSY 20002632 1 Yes
4 FRU-PCB SUB ASSY 20002647 1 Yes
5 FRU-DGC KNOB 20001666 1 Yes
6 FRU-PCB MAIN ASSY 20002645 1 Yes
7 FRU-DGC ASSY 20000276 1 Yes
8 FRU-KEYBOARDD ASSY 20000128 1 Yes
9 FRU-TRACKBALL ASSY 20000270 1 Yes
10 FRU-CP_COVER 20002633 1 Yes
Table 6-4 Control panel

181
6-5 Covers

11

16

12

15

14
13

Figure 6-4 Covers


Item Part name Part number Q’ty Rev. 1.0
11 FRU-BODY_FRONT_COVER 20002664 1 Yes
12 FRU-BODY_REAR_COVER_ASSY 20002665 1 Yes
13 FRU-BODY_SIDE_COVER_R 20002667 1 Yes
14 FRU-BODY_SIDE_COVER_L 20002668 1 Yes
15 FRU-BODY_TOP_COVER 20002669 1 Yes
16 FRU-BODY_TOP_REAR_COVER 20002670 1 Yes
Table 6-5 Covers

182
6-6 TI/FE

19

18

17

22

21

20

Figure 6-5 TI/FE

Item Part name Part number Q’ty Rev. 0 Rev. 1


17 FRU-BP BOARD ASSY SVC00121 1 Yes
18 FRU-FE BOARD ASSY SVC00122 1 Yes
19 FRU-80mm FAN 20002652 1 Yes
20 FRU-TI BOARD ASSY SVC00123 1 Yes
21 FRU-TI BOARD ASSY V2.0 20002961 1 No Yes
22 FRU-TIFE_ASSY 20002648 1 Yes
Table 6-6 TI/FE

183
6-7 Frame

21
22

23

27

24

26
25

Figure 6-6 Frame

Item Part name Part number Q’ty Rev. 1.0


21 FRU-GEL_CUP 20002678 1 Yes
22 FRU-PROBE_CUP 20002679 1 Yes
23 FRU-PROBE_CUP_LARGE 20002680 1 Yes
24 FRU-DVD_RW_SH-222AB 20002208 1 Yes
25 FRU-CASTER ASSY SVC00034 1 Yes
26 FRU-LC ARM COVER SET SVC00037 1 Yes
27 FRU-LC ARM ASSY SVC00036 1 Yes
Table 6-7 Frame

184
6-8 Cables

28 29

30 31
32

33
34

Figure 6-7 Cables

Item Part name Part number Q’ty Rev.1.0


28 FRU-CABLE_BEIO_SATA_TO_HDD_SATA_7V10 20002770 1 Yes
29 FRU-CABLE_BEIO_SATA_TO_FE_SATA_7V10 20002771 1 Yes
30 FRU-CABLE_ACDC_PWR_TO_BEIO_PWR_7V10 20002772 1 Yes
31 FRU-CABLE_ACDC_PWR_TO_BP_PWR22_7V10 20002773 1 Yes
32 FRU-CABLE_ACDC_PWR_TO_BP_PWR24_7V10 20002774 1 Yes
33 FRU-CABLE_BEIO_USB_TO_EXTERNAL_USB_7V10 20002768 1 Yes
34 FRU-CABLE_BEIO_SATA_TO_DVD_RW_SATA_7V10 20002769 1 Yes
Table 6-8 Cables

185
6-9 HDD

35

Figure 6-8 HDD

Item Part name Part number Q’ty Rev. 0


35 FRU-HDD ASSY FOR ECUBE-7 SVC00044 1 Yes
Table 6-9 HDD

6-10 IO

36
37 Figure 6-9 IO

Item Part name Part number Q’ty Rev. 0


36 FRU-COMEXPRESS ASSY FOR E-CUBE7 SVC00114 1 Yes
37 FRU-IO BOARD ASSY SVC00109 1 Yes
Table 6-10 IO

186
6-11 Monitor

49
48

Monitor Assy LCD OPEN FRAME Assy (19 inch)

50
51

SPEAKER Assy (19 inch) OSD BUTTON Assy (19 inch)

52

LAMP Assy (19 inch)


Figure 6-10 Monitor

Item Part name Part number Q’ty Rev. 1.0


48 FRU-19 inch MONITOR ASSY SVC00088 1 Yes
49 FRU-19 inch LCD PANEL ASSY SVC00087 1 Yes
50 FRU-19 inch SPEAKER ASSY SVC00091 1 Yes
51 FRU-19 inch OSD BUTTON ASSY SVC00090 1 Yes
52 FRU-19 inch LAMP ASSY SVC00086 1 Yes
Table 6-11 Monitor

187
6-12 Probe (Transducer)

1 2 3

4 5

Figure 6-11 Probe

Item Part name Part number Q’ty Rev. 1.0


1 C1-6 PROBE 10000266 1 Yes
2 SP1-5 PROBE 10000232 1 Yes
3 L3-12 PROBE 10000231 1 Yes
4 E3-10 PROBE 10000230 1 Yes
5 EN3-10 PROBE 10000600 1 Yes
Table 6-12 Probe

188
Chapter 7. System
7-1 System Care and Maintenance
It is the responsibility of the user to verify that the ultrasound system is safe for diagnostic
operation on a daily basis. Each day, prior to using the system, perform each of the steps in
the daily checklist.

All exterior parts of the system, including the control panel, keyboard, and transducers,
should be cleaned and/or disinfected as necessary or between uses. Clean each component
to remove any surface particles. Disinfect components to kill vegetative organisms and
viruses.

The air filter on the ultrasound system must be cleaned regularly to maintain proper system
cooling. Remove and check the air filter weekly, and clean as needed.

CAUTION:
• The system does not contain any operator serviceable internal components. Ensure that
unauthorized personnel do not tamper with the unit.
• When defects or malfunctions occur, do not operate the system until the problems are
resolved. Contact your local service representative.

7-1-1 Daily checklist


Perform the following each day before using the ultrasound system:

 Visually inspect all transducers. Do not use a transducer which has a cracked,
punctured, or discolored casing or frayed cable.
 Visually inspect all power codes. Do not turn on the power if a cord is frayed or split, or
shows signs of wear. If your system’s power cord is frayed or split, or shows signs of
wear, contact your ALPINION service representative for power cord replacement.

 Visually that the trackball and other controls on the control panel are clean and free
from gel or other contaminants.

WARNING: To avoid electrical shock, you must visually inspect a transducer prior to use. Do
not use a transducer that has a cracked, punctured, or discolored casing or a frayed cable.

189
7-1-2 Monthly checklist
To inspect the system, examine the following on a monthly basis.

 Connectors on cables for any mechanical defects

 Entire length of electrical and power cables for cuts or abrasions

 Control panel and keyboard for defects

 Casters for proper locking operation

NOTE: To maintain the safety and functionality of the ultrasound system, maintenance must
be performed every 12 months. Electrical safety tests must also be performed at regular
intervals as specified by local safety regulations. Refer to the service manual for the
electrical leakage test.

WARNING: When the LED lamp needs to be replaced, contact the ALPINION service
representative.

CAUTION: To avoid electrical shock hazard, do not remove panels or covers from the
console. This service must be performed by qualified service personnel. Failure to do so
could cause a serious injury

7-1-3 Weekly maintenance


The system requires weekly care and maintenance to function safely and properly. Clean the
following:

 Monitor
 control panel
 Footswitch

Failure to perform required maintenance may result in unnecessary service calls.

190
7-1-4 Cleaning the system
Prior to cleaning any part of the system:

- Turn off the system power. If possible, disconnect the power cord.

7-1-4-1 Cleaning the surface of the ultrasound system

CAUTION: Do not spray any liquid directly into the unit when cleaning the system.

1. Use a clean gauze pad or lint-free cloth, lightly moistened with a mild detergent, to
wipe the surface of the ultrasound system. Take particular care to clean the areas
near the trackball and the slide controls. Ensure these areas are free of gel and any
other visible residue.

Ensure that cleaning solution does not seep into the control panel, keyboard, or any
other openings.

2. After cleaning, use a clean, lint-free cloth to dry the surface.

3. After cleaning, reconnect the ultrasound system power code into the power outlet.

7-1-4-2 Cleaning the liners of the transducer holders

1. Use the tab to remove the liner from the transducer holder.

2. Clean the liner under running water, using a mild detergent and dry with a lint-free
cloth.

3. Reinsert the liner into the transducer holder.

191
7-1-4-3 Cleaning the trackball

CAUTION: Do not drop or place foreign objects inside the trackball assembly. This may
affect the trackball’s operation and damage the system. Avoid other solvents that may
damage the mechanical parts of the trackball assembly.

74. Remove the front panel bezel by rotating the bezel counter-clockwise.

75. Remove the trackball and the teflon ring.

76. Clean the trackball and the teflon ring with tissue and isopropyl alcohol.

77. Clean the inside of the trackball assembly with a cotton swab and isopropyl alcohol.

78. Allow the assembly parts to completely dry before reassembly.

79. Replace the trackball and front panel bezel.

7-1-4-4 Cleaning the monitor face

Use a soft, folded cloth and a glass cleaner solution. Apply the glass cleaner to the cloth.
Gently wipe the monitor face.
Do NOT use a glass cleaner that has a hydrocarbon base (such as Benzene, Methyl
Alcohol or Methyl Ethyl Ketone) on monitors with the filter (anti-glare shield). Prolonged
use of such cleaners will damage the filter (anti-glare shield). Hard rubbing will also
damage the filter.

CAUTION: When cleaning the monitor, make sure not to scratch the monitor.

192
7-1-4-5 Removing and cleaning the air filter
The air filter on the ultrasound system must be cleaned regularly to maintain proper
system cooling. Remove and check the air filter weekly, and clean as needed.

CAUTION: Do not scrub, stretch, or bend the filter, or apply heat to the filter, as doing so
could damage the filter.

1. Power off and unplug the power code from the power outlet.
2. Grasp the air filter tray and pull it out of the system.
3. Rinse the air filter with running water and allow the filter to completely dry. To hasten
drying, you may gently shake the filter, or blot the filter with a clean, lint-free cloth.
4. Reinsert the filter into the filter tray.
5. Plug the power cord into the power outlet.

193
7-2 Transducer Care and Maintenance
It is the responsibility of the user to verify that the transducer is safe for diagnostic operation.
After each use, inspect the transducer's lens, cable, and casing. Look for any damage that
would allow liquid to enter the transducer. If any damage is found, do not use the transducer
until it has been inspected and repaired/replaced by ALPINION Service Representative.

WARNING: Always place a sterile, non-pyrogenic transducer sheath on a transducer used in


procedures requiring sterility.

WARNING: To minimize the risk of cross-contamination and infectious diseases,


intraoperative transducers must be cleaned and high-level disinfected after each use. A
sterile, non-pyrogenic transducer sheath must be in place during procedures requiring
sterility.

WARNING: There have been reports of severe allergic reactions to medical devices
containing latex (natural robber). Health care professionals are advised to identify latex-
sensitive patients and to be prepared to treat allergic reactions promptly.

WARNING: During neurosurgical procedures, if a transducer becomes contaminated with


tissue or fluids of a patient known to have Creutzfeld-Jacob disease, the transducer should
be destroyed, as it cannot be sterilized.

WARNING: When using an endocavity or intraoperative transducer with a CF type applied


part, the patient leakage currents may be additive.

WARNING: To avoid electrical shock and damage to the system, disconnect the transducer
prior to cleaning or disinfecting.

WARNING: The list of disinfectants and cleaning methods listed are recommended by
ALPINION form compatibility with product materials, not for biological effectiveness. Refer to
disinfectant label instructions for guidance on disinfection efficacy and appropriate clinical
uses.

CAUTION: Transducers are sensitive instruments – irreparable damage may occur if they
are dropped, knocked against other objects, cut, or punctured. Do not attempt to repair to
alter any part of a transducer.

CAUTION: To avoid cable damage, do not roll the system over transducer cables.

CAUTION: To avoid damage to the transducer, do not use transducer sheaths containing on
oil-based coating or petroleum-or mineral oil-based ultrasound coupling agents. Use only a
water-based ultrasound coupling agent.

CAUTION: DO NOT place or store the transducer in the side pocket or the storage area on
the system to prevent damaging it from accidently falling off.

194
CAUTION: To avoid damage to the transducer, observe the immersion levels indicated for
each transducer type. Do not immerse or allow the cable or connector of a transducer to
become wet. See Figure 7‐1 on page 10‐10 for more detailed information.

CAUTION: The transducer have been designed and tested to be able to withstand high-level
disinfection as recommended by the manufacturer of the disinfectant product. Carefully
follow the disinfectant manufacturer’s instructions. Do not immerse for more than one hour.

7-2-1 Transducer handling and infection control


This information is intended to increase user awareness of the risks of disease transmission
associated with using this equipment and provide guidance in making decisions directly
affecting the safety of the patient as well as the equipment user.

Diagnostic ultrasound systems utilize ultrasound energy that must be coupled to the patient
by direct physical contact. Depending on the type of examination, this contact occurs with a
variety of tissues ranging from intact skin in a routine exam to recirculating blood in a
surgical procedure. The level of risk of infection varies greatly with the type of contact.

One of the most effective ways to prevent transmission between patients is with single use
or disposable devices. However, ultrasound transducers are complex and expensive devices
that must be reused between patients. It is very important, therefore, to minimize the risk of
disease transmission by using barriers and through proper processing between patients

195
7-2-2 Cleaning and disinfecting transducers
To clean a transducer,

1. Disconnect the transducer from the system.


2. Moisten a clean gauze pad with water and wipe the transducer to remove any gel or
particles remaining on the transducer. If water is not effective, then you can use an
approved pre-cleaner or low-level disinfectant.
3. Carefully wipe the entire transducer, including the cable and connector.
4. After cleaning or disinfecting, use a clean cloth to dry the transducer.

To disinfect or high-level disinfect a transducer,

1. Disconnect the transducer from the system.


2. Thoroughly clean, rinse, and dry the transducer.
3. Take care to keep the cable strain relief and connector of the transducer dry while
immersing the transducer in an approved disinfectant to the level indicated in the following
illustration.
4. Carefully follow the disinfectant manufacturer’s instructions for disinfection or high-level
disinfection.
5. After disinfecting or high-level disinfecting, use a clean cloth to dry the transducer.

The following high-level disinfectant agents have been approved for use with all transducers:

 Cidex OPA

 Cidex Plus

196
7-2-3 IPX8 immersion levels
CAUTION: To avoid damage to the transducer, observe the immersion levels indicated for
each transducer type. Transducers with the protection level IPX8 are indicated by the
presence of the “IPX8” symbol on the connector of the transducer.

Transducers meet Ingress Protection IPX8 of EN 60539 and IEC 60539 to the depth of the
immersion line shown in the illustration only for transducers with the “IPX8” symbol on the
connector of the transducer.

Connector

Strain relief

Figure 7-1 IPX8 immersion level

197
7-2-4 Cable handling
Take the following precautions with transducer cables:

 Keep free from wheels


 Do not bend the cable acutely
 Avoid crossing cables between transducers

7-2-5 Planned maintenance


The following maintenance schedule is suggested for the transducer to ensure optimum
operation and safety.

 Daily: inspect transducers


 After each use: clean transducers
 After each use: disinfect transducers

198
Chapter 8. Safety and Regulatory Information
This chapter introduces the followings:

 Safety Summary

 Important Safety Warnings

 Patient Safety Information

 Electrical Safety Information

 Transducer Safety Information

 System Symbols and Labels

 Regulatory Information

 Electromagnetic Compatibility (EMC)

 Peripheral Update for EC Countries

 Acoustic Output

199
8-1 Safety Summary
You should make sure the following safety precautions during all phases of operation, service, and
repair of the E-CUBE 7 ultrasound system. If you fail to comply with these safety precautions or
specific warnings in this manual, you violate safety standards in terms of design, manufacture, and
intended use of this system. ALPINION MEDICAL SYSTEMS Co., LTD. does not have liability for
your failure to comply with these requirements.

8-1-1 Safety notice


WARNING
A WARNING notice indicates a hazard. You need to observe an operating procedure, practice,
or the like that. If you do not correctly perform this notice, it could result in personal injury or
death.

CAUTION
A CAUTION notice indicates a hazard. You need to observe an operating procedure, practice, or
the like that. If you do not correctly perform this notice, it could result in damage to the system or
loss of important data.

8-1-2 Service document


The Service Manual supplies block diagrams, lists of spare parts, descriptions, adjustment
instructions or similar information which help adequately qualified technical personnel in
repairing those parts of the instrument which have been defined repairable by the manufacturer.

200
8-2 Important Safety Warnings
WARNING
 Installing the system yourself may cause damage to the system or electrical shock.

 To avoid damage to the system and avoid electrical shock, only qualified ALPINION service
engineer must install the system.

 Do not remove the covers of a system yourself to avoid damage to the system and unexpected
electrical shock. Only qualified ALPINION service engineer must repair or replace components.

 Before cleaning up and disinfecting the system, always make sure you turn off the system
power and unplug the power cord from the power outlet.

 To avoid risk of electric shock, you must connect the system to the supply mains with the
protective earth.

 Do not allow water or liquids on or above the system. Dripping water or liquids into the system
may cause electrical shock and damage to the system.

 Always use peripherals and accessories approved by ALPINION. You must securely connect
peripherals and accessories to the system.

 Do not modify this system such as system components, or software. When you modify the
system, it may cause safety hazards. Only qualified ALPINION service engineer must modify
the system.

 Always use the system properly to avoid serious injury. Before using the system, you must
make sure the instructions and hazards involving ultrasound system. ALPINION provides
training assistance, if needed.

 Always use transducers approved or recommended by ALPINION.

 You must follow safety precautions and avoid any situation that causes injury or damage.

 The system voltage may cause serious injury or damage to the system.

 When you observe that the system causes any malfunction, you must stop operating the
system and take proper action for patients. After that, contact ALPINION service engineer.

 You must make sure grounded integrity of the power outlet and system regularly.

 Always make sure that you do not use the system in an explosive atmosphere.

 For patient safety, you must locate the system to easily unplug the power cord from the power
outlet when a malfunction or an error occurs.

201
8-3 Patient Safety Information

WARNING
 When you enter patient data, always make sure that you enter correct identification with
patient data.

 Do not use the system until you become familiar with the system operation.

 To avoid the transducer from overheating, you must freeze the system when imaging is not
performed.

CAUTION
 Do not allow the system to transmit acoustic output when not using the transducer. Otherwise,
it could result in overheating of the transducer.

 When not using the system, you should freeze the image or turn off acoustic output.

 Do not use the system with defibrillator.

 Do not allow the germicide to contact your patient. Contact to the patient’s skin or mucous
membrane may cause an inflammation.

202
8-4 Electrical Safety Information
WARNING
 Do not clean or disinfect a system before turning off and unplug the system from the power
outlet. Otherwise, it could result in electrical shock and damage to the system.

 Do not place water or liquids on the system. Dripping water or liquids into the system may
cause electrical shock and damage to the system.

 Do not remove the panels or covers of a system to prevent system damage and electrical
shock.

 Do not use extension cords, adaptors or converters, which are a three-prong to two-prong type,
to connect with a power plug.

 The system voltage may cause serious injury or damage to the system. When you observe
that the system causes any malfunction, you must stop operating the system and take proper
action for patients. After that, contact ALPINION service engineer.

 Do not modify the AC power connector plug of the system to prevent electrical shock.

 You should use the ultrasound system after few hours when leaving it in humidity place.

 Do not connect, disconnect, or replace any part of a system during scanning a patient at the
same time.

 Do not place a fuse or power cord by yourself. An ALPINION MEDICAL service engineer or an
authorized agent must perform the replacement. Replacing the fuse or power cord by yourself
will avoid your warranty.

 Using spray cleaners on the system drips cleaning fluid into the system. It damages
components in the system.

 Do not use aerosol spray cleaners on the monitor to prevent electrical shock and damage to
the system.

 Different voltage power between your system and other devices may cause electrical shock.
According to the IEC requirements (Refer to IEC 60601‐1‐1 and clause 16 of the 3 Ed.
of IEC 60601‐1, respectively), you must use the equipotential cable (equipotential bonding)
to connect additional devices to your system. Contact your ALPINION MEDICAL service
engineer.

203
8-5 Transducer Safety Information
Damaged transducers or improper use and manipulation of the transducer may result in
injury or increased risk of infection.

Never use excessive force when manipulating intracavity transducers. Become familiar with
all instructions and precautions provided with special purpose transducers.

The use of damaged transducers can result in injury or increased risk of infection. Inspect
transducer often for sharp, pointed, or rough surface damage that could cause injury or tear
protective barriers.

WARNING

 Do not use damaged or defective transducer to prevent system damage and serious patient
injury.

 Make sure you do not bend or pull the transducer cable to prevent the damage to the
transducer.

 Use only approved coupling gels. Using unapproved gels may damage the transducer and
void the warranty.

CAUTION
 Do not drop the transducer. Always keep the transducer secure when you do not use it.

 Using damaged or defective transducer causes unexpected electric shock. Make sure the use
and care of the transducer accordingly.

 Do not allow the system to transmit acoustic output when the transducer is not in use.
Otherwise, it could result in overheating of the transducer.

 When not using the system, you should freeze the image or turn off acoustic output.

 To avoid serious patient injury, always inspect the transducer that you use has sharp edges
and rough surfaces.

 Proper cleaning and disinfecting the transducer prevent disease transmission. You must follow
infection control procedures.

204
 Make sure that you do not use an expired transducer sheath.

 Using pre-lubricated condoms as a sheath might damage the transducer.

 Do not allow your eyes (or patient’s eyes) to contact the coupling gel. If there is gel contact to
the eyes, flush thoroughly with clean water.

8-5-1 Transducer surface temperature limits


Maximum Temperature (°C)
Transducer Tissue Mimicking Material Still Air 
(TMM)
C1‐6 32.7 40.6
E3‐10 32.6 42.7
EN3‐10 29.9 43.1
L3‐8 28.6 43.4
L3‐12 27.5 38.5
L3‐12H 27.9 40.3
SC1‐6 28.7 43.1
SP1‐5 31.9 41.0
SP3‐8 28.4 42.6
VC1‐6 28.9 43.8
8-6 System Symbols and Labels
The following is a list of system symbols and labels for safety. They indicate that you must
refer to the manual for specific information to avoid personal injury or damage to the product.
Safety symbols/ Labels Location Explanation
On the power button of System on/off/stand‐by
the control panel

On the system rating Patient applied part meets the isolation


label for overseas and requirements for type BF equipment
transducer label

On the transducer label This symbol indicates that the transducer


meets immersion requirements. Depending on
the transducer model, the immersion label
may differ.

On the multi‐caution This symbol indicates that when the end ‐user
label and transducer wishes to discard this product, it must be sent
label to separate collection facilities for recovery
and recycling. By separating this product from
other household‐type waste, the volume of
waste sent to incinerators or land ‐fills will be
reduced and natural resources will thus be
conserved. Please contact an authorized
representative of the manufacturer for
information concerning the decommissioning
of your equipment

On the multi‐caution This system complies with regulatory


label, rating label for requirements of European Directive 93/42/EEC
overseas, and system regarding medical device.
packing box

Rear of the system body Consult instructions for use (or consult
operating instructions)

Various locations on Attention (Caution) – consult accompanying


labels documents if complete information cannot be
provided on the label
206
Safety symbols/ Labels Location Explanation
On the rating label for Alternating current in accordance with
overseas: Adjacent to IEC60878‐01‐14
the AC power

Adjacent to the AC Push‐push button


power

Adjacent to the AC Equipotentiality


power

On the control panel Universal Serial Bus


cover

On the system rating Date of manufacture See ISO 8601 for date format
label for overseas and
transducer label

On the system rating Symbol for manufacturer This symbol shall be


label for overseas and accompanied by the name and the address of the
transducer label manufacturer.

On the system rating Serial Number


label for overseas and
transducer label
Rear of the system To ensure safety of user, moving and delivering
body system shall be performed by at least 2 persons.

Rear of the LCD monitor Do not forcibly push the monitor or the system
Rear of the system when the casters are locked.
body cover

Rear of the LCD monitor Do not press or place loads on the monitor when
folded. Otherwise, monitor and (or) monitor arm
could be damaged.

Rear of the system Do not use mobile transmitter such as mobile


body phone, radio receiver, broadband power line, etc

Rear of the LCD monitor Be very careful not to injure yourself or damage
the system when rotating the monitor arm.

207
Safety symbols/ Labels Location Explanation
Rear of the LCD monitor

Top of the monitor arm Care against pinch shall be taken. (In
accordance with IEC60878)

Rear of the system body

Side panel of the system


body

Bottom of the control panel

Bottom of the control panel

Transducer Name of transducer manufacturer,


Authorized EU Representative, Safety,
WEEE symbol, indicating separate
collection, Certification mark

Transducer Transducer name, Serial, IPX Rating,


Manufacturer date, Caution mark

208
8-7 Regulatory Information
The E-CUBE 7 ultrasound system conforms to the following classifications, in accordance
with the IEC/EN 60601-1:6.8.1:

Classifications:

 Type of protection against electrical shock: Class I


 Degree of protection against electrical shock (Patient connection): Type BF equipment
 Degree of protection against harmful ingress of water: Ordinary equipment and all of
applied parts (IPX 7 and IPX 8) except ECG meet ingress protection level according to
IEC 60529.
 Degree of safety of application in the presence of a flammable anesthetic material with
air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or nitrous oxide.
 Mode of operation: Continuous operation

The E-CUBE 7 ultrasound system conforms to the following standards:

 EN 60601-1: 1990+A1:1993+A2:1995+A13:1995 (IEC 60601-1:1988+A1:1991+A2:1995)


 EN 60601-1-1 : 2001 (IEC 60601-1-1 : 2000)
 EN 60601-1-2:2001+A1:2006 (IEC 60601-1-2:2001+A1:2004)
 EN 60601-1-4:1996+A1:1999 (IEC 60601-1-4: 1996+A1:1999)
 EN60601-2-37:2001+A1:2005+A2:2005 (IEC 60601-2-37:2001+A1:2004+A2:2005)
 EN 55022:2006+A1:2007, Class B (CISPR 22:2005+A1:2005)
 EN 55011:2007+A2:2007, Group 1, Class B (CISPR 11:2003+A2:2006)
 EN 61000-4-2:1995+A2:2001(IEC61000-4-2:1995+A2:2000)
 EN 61000-4-3:2006 (IEC 61000-4-3:2006)
 EN 61000-4-4:2004 (IEC 61000-4-4:2004)
 EN 61000-4-5:2006 (IEC 61000-4-5:2005)
 EN 61000-4-6:2007 (IEC 61000-4-6:2003+A1:2004+A2:2006)
 EN 61000-4-8:1993+A1:2001(61000-4-8:1993+A1:2000)
 EN 61000-4-11:2004 (IEC 61000-4-11:2004)
 EN 61000-3-2:2006+A2:2009 (IEC 61000-3-2:2005+A2:2009)
 EN 61000-3-3:2008 (IEC 61000-3-3:2008)
 ISO 10993-1:2009
 NEMA/AIUM Acoustic Output Display Standard (NEMA US-3, 1998)
 EN 60601-1:2006 (IEC60601-1:2005)
 EN 60601-1-2:2007(IEC 60601-1-2:2007)
 EN 60601-2-37 :2008 (IEC 60601-2-37:2007)
 ISO13485:2003+AC:2009
 ISO14971:2007:AC2009
 ISO14155:2009

Authorized EU Representative

European registered place of business:

Name: Thomas Roth


Address: Lilienthalstrasse 17a, 85399 Hallbergmoos, Germany
Phone: +49 (0) 811 99 82 86 0

209
8-8 Electromagnetic Compatibility (EMC)
This equipment generates uses and can radiate radio frequency energy. The equipment may
cause radio frequency interference to other medical and non-medical devices and radio
communications. To provide reasonable protection against such interference, this product
complies with emissions limits for a Group 1, Class Medical Devices Directive as stated in
EN 60601-1-2. However, there is no guarantee that interference will not occur in a particular
installation.

If this equipment is found to cause interference (which may be determined by turning the
equipment on and off), the user (or qualified service personnel) should attempt to correct the
problem by one or more of the following measure(s):

 reorient or relocate the affected device(s)

 increase the separation between the equipment and the affected device

 power the equipment from a source different from that of the affected device

 consult the point of purchase or service representative for further suggestions

The manufacturer is not responsible for any interference caused by using other than
recommended interconnect cables or by unauthorized changes or modifications to this
equipment. Unauthorized changes or modifications could void the users’ authority to operate
the equipment.

Do not use devices which intentionally transmit RF Signals (cellular phones, transceivers, or
radio controlled products) in the vicinity of the equipment as it may cause performance
outside the published specifications. Keep the power to these type devices turned off when
near this equipment.

The medical staff in charge of this equipment is required to instruct technicians, patients, and
other people who maybe around this equipment to fully comply with the above requirement.

210
8-8-1 Recommended separation distances between portable and mobile RF
communications equipment and the E-CUBE 7
The E-CUBE 7 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the E-CUBE 7 can help Prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the E-CUBE 7 as recommended
below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter


[m]
Rated
maximum 80 MHz to 800 800 MHz to
output 150 kHz to 80 MHz
MHz 2.5 GHz
power of
transmitter
[W]
E1= 3 E1= 3
V1= 3 Vrms V1=1 Vrms V1=0.3 Vrms
V/m V/m
0.01 0.12 0.35 1.17 0.11 0.23
0.1 0.37 1.09 3.62 0.36 0.73
1 1.17 3.50 11.67 1.16 2.33
10 3.69 11.10 36.87 3.68 7.37
100 11.66 35.00 116.67 11.66 23.33

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where p is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1) At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

8-8-2 Immunity and compliance level for system

Frequency of Interest Actual Immunity


Immunity test Compliance Level
[MHz] Level

Conducted RF
0.15 MHz to 80 MHz 3 Vrms 0.3 Vrms
IEC 61000-4-6

80 MHz to 800 MHz 3V/m 1V/m


Radiated RF
IEC 61000-4-3
800 MHz to 2.5 GHz 3V/m 3V/m

211
8-8-3 Immunity and compliance level for transducer

Conducted RF IEC 61000-4-6

▶ Transducer: C1-6, 2 Hz, C mode

Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]

0.36 MHz to 17.62 MHz 3 Vrms

37.91 MHz 3 Vrms

0.66 MHz to 14.58 MHz 1 Vrms

Conducted RF IEC 61000-4-6 0.81 MHz to 13.20 MHz 0.3 Vrms*

* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system
ambient background noise.
** Between 0.15 MHz ~ 0.35 MHz, 17.79 MHz ~ 37.53 MHz and 38.29 MHz ~ 80.00 MHz the level
of Immunity is 3 Vrms.

212
▶ Transducer: EN3-10, 2 Hz, C mode

Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]

2.63 MHz to 20.25 MHz 3 Vrms

25.21 MHz to 36.79 MHz 3 Vrms

3.02 MHz to 17.97 MHz 1 Vrms

25.71 MHz to 36.09 MHz 1 Vrms

Conducted RF
IEC 61000-4-6 5.08 MHz to 14.01 MHz 0.3 Vrms*

* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system
ambient background noise.
** Between 0.15 MHz ~2.60 MHz, 20.45 MHz ~ 24.96 MHz and 387.16 MHz ~ 80.00 MHz the
level of Immunity is 3 Vrms.

213
▶ Transducer: EN3-10, 2 Hz, C mode

Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]

0.81 MHz to 39.06 MHz 3 Vrms

2.68 MHz to 35.71 MHz 1 Vrms

Conducted RF
IEC 61000-4-6 3.88 MHz to 17.27 MHz 0.3 Vrms*

* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system
ambient background noise.
** Between 0.15 MHz ~ 0.80 MHz and 39.45 MHz ~ 80.00 MHz the level of Immunity is 3
Vrms.

214
▶ Transducer: L3-12, 2 Hz, C mode

Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]

3.12 MHz to 18.33 MHz 3 Vrms

26.76 MHz to 37.53 MHz 3 Vrms

3.37 MHz to 16.76 MHz 1 Vrms

27.03 MHz to 32.98 MHz 1 Vrms

Conducted RF 27.30 MHz to 32.01 MHz 0.3 Vrms*


IEC 61000-4-6

3.67 MHz to 15.79 MHz 0.3 Vrms*

* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system ambient
background noise.
** Between 0.15 MHz ~ 3.08 MHz, 18.52 MHz ~ 26.49 MHz and 37.91 MHz ~ 80.00 MHz the
level of Immunity is 3 Vrms..

215
▶ Transducer: SP1-5, 2 Hz, C mode

Frequency of Interest**
Image at Frequency of Interest Actual Immunity Level
[MHz]

0.76 MHz to 24.47 MHz 3 Vrms

1.04 MHz to 14.74 MHz 1 Vrms

1.39 MHz to 7.05 MHz 0.3 Vrms*


Conducted RF
IEC 61000-4-6

* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system
ambient background noise.
** Between 0.15 MHz ~ 0.75 MHz and 24.71 MHz ~ 80.00 MHz the level of Immunity is 3
Vrms.

216
8-8-4 Guidance and manufacturer’s declaration –electromagnetic emissions

This system is suitable for use in the following environment. The user must assure that it is
used only in the electromagnetic environment as specified.

The E-CUBE 7 is intended for use in the electromagnetic environment specified below. The
customer or the user of the E-CUBE 7 should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

The E-CUBE 7 uses RF energy only for its


RF emissions internal function. Therefore, its RF emissions are
Group 1
CISPR 11 very low and are not likely to cause any
interference in nearby electronic equipment.

RF emissions The E-CUBE 7 is suitable for use in all


Class B
CISPR 11 establishments, including domestic
establishments and those directly connected to
Harmonic emissions the public low-voltage power supply network that
Class A supplies buildings used for domestic purposes.
IEC 61000-3-2

Voltage fluctuations /
flicker emissions Complies
IEC 61000-3-3

217
8-8-5 Guidance and manufacturer’s declaration-electromagnetic immunity

The E-CUBE 7 is intended for use in the electromagnetic environment specified below.
The customer or the user of the E-CUBE 7 should assure that it is used in such an environment.

IEC 60601 Electromagnetic


Immunity test Compliance level
Test level environment -guidance
Electrostatic ±6 kV Contact ±6 kV Contact Floors should be wood,
discharge (ESD) concrete or ceramic tile. If
±8 kV air ±8 kV air floors are covered with
IEC 61000-4-2 synthetic material, the
relative humidity should be
at least 30 %.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should
transient/burst supply lines supply lines be that of a typical
±1 kV for input/output ±1 kV for commercial or hospital
IEC 61000-4-4 lines input/output lines environment.

Surge ±1 kV differential mode ±1 kV differential Mains power quality should


±2 kV common mode mode be that of a typical
IEC 61000-4-5 ±2 kV common commercial or hospital
mode environment.

Voltage dips, short < 5 % Uт < 5 % Uт Mains power quality should


interruptions and (> 95 % dip in Uт) (> 95 % dip in Uт) be that of a typical
voltage variations for 0.5cycle for 0.5cycle commercial or hospital
on power supply environment. If the user of
input lines 40 % Uт 40 % Uт the E-CUBE 7 image
(60 % dip in Uт ) (60 % dip in Uт ) intensifier requires
IEC 61000-4-11 for 5 cycle for 5 cycle continued operation during
power mains interruptions,
70 % Uт 70 % Uт it is recommended that the
(30 % dip in Uт) (30 % dip in Uт) E-CUBE 7 image intensifier
for 25 cycle for 25 cycle be powered from an
uninterruptible power
<5 % Uт < 5 % Uт supply.
(< 95 % dip in Uт ) (< 95 % dip in Uт )
for 5 s for 5 s
Power frequency 3A/ m 3A/ m Power frequency magnetic
(50/60 Hz) fields should be at levels
magnetic field characteristic of a typical
location in a typical
IEC 61000-4-8 commercial or hospital
environment.

NOTE: Uт is the a.c. mains voltage prior to application of the test level.

218
8-8-6 Guidance and manufacturer’s declaration-electromagnetic immunity

Immunity IEC 60601 test Compliance


Electromagnetic environment - guidance
test level level
Portable mobile RF communications equipment
Conducted 3 Vrms Please see should be used no closer to any part of the
RF 150 kHz to 80 the page 91 to E-CUBE 7, including cables, than the recommended
IEC MHz 97 separation distance calculated from the equation
61000-4-6 applicable to the frequency of the
transmitter.

Recommended separation distance

3V/m
3V/m 80 MHz to 2.5
Radiated 80 MHz to 2.5 GHz
RF GHz
IEC
80 MHz to 800 MHz
61000-4-3

800 MHz to 2.5 GHz

where P is the maximum output power rating of


the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as


a
deter-mined by an electromagnetic site survey,
should be less than the compliance level in each
b
frequency range.

Interference may occur in the vicinity of


equipment marked with the following symbol :

NOTE 1 ) At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the EUT is used exceeds the applicable RF compliance level above, the EUT should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the E-CUBE 7.
b
Over the frequency range 150 kHz to 80MHz, field strengths should be less than [V1] V / m.

219
8-8-7 Diagnostic ultrasound indications for use format
E-CUBE 7 Ultrasound System

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation


B M PWD CWD Color Power Tissue Combined* Other**
Doppler Doppler Harmonic
Imaging (Specify) (Specify)
Ophthalmic
Fetal P P P P P P P
Abdominal P P P P P P P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P P
Small Organ (Specify) P P P P P P P
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P P P
Trans-vaginal P P P P P P
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P P
(Conventional)
Musculo-skeletal P P P P P P P
(Superficial)
Intravascular
Other (Specify) P P P P P P P
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P P P P P P P
Urology (including prostate) P P P P P P P

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

220
E-CUBE 7 with C1-6 Transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation


B M PWD CWD Color Power Tissue Combined* Other**
Doppler Doppler Harmonic
Imaging (Specify) (Specify)
Ophthalmic
Fetal P P P P P P P
Abdominal P P P P P P P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P P
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Urology (including prostate) P P P P P P P

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

221
E-CUBE 7 with E3-10 Transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation


B M PWD CWD Color Power Tissue Combined* Other**
Doppler Doppler Harmonic
Imaging (Specify) (Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P P P
Trans-vaginal P P P P P P
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Urology (including prostate) P P P P P P

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

222
E-CUBE 7 with EN3-10 Transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation


B M PWD CWD Color Power Tissue Combined* Other**
Doppler Doppler Harmonic
Imaging (Specify) (Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P P P
Trans-vaginal P P P P P P
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Urology (including prostate) P P P P P P

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

223
E-CUBE 7 with L3-12 Transducer-CUBE 7

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation


B M PWD CWD Color Power Tissue Combined* Other**
Doppler Doppler Harmonic
Imaging (Specify) (Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P P
Small Organ (Specify) P P P P P P P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal P P P P P P P
(Conventional)
Musculo-skeletal P P P P P P P
(Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P P P P P P P
Urology (including prostate)

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

224
E-CUBE 7 with SP1-5 Transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation


B M PWD CWD Color Power Tissue Combined* Other**
Doppler Doppler Harmonic
Imaging (Specify) (Specify)
Ophthalmic
Fetal
Abdominal P P P P P P P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P P P
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Other (Specify)
Cardiac Adult P P P P P P P
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA; E = added under this appendix

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

225
Transducer/Mode Combination Summary

System: E-CUBE 7

NA: Not Applicable

Transducer Model Mode of Operation

B M PWD CWD Color Combined Other


Doppler (Specify) (Specify)
L3‐12 O O O NA O O NA

C1‐6 O O O NA O O NA

E3‐10 O O O NA O O NA

EN3‐10 O O O NA O O NA

SP1‐5 O O O NA O O NA

226
Display resolution and measurement accuracy
When a transducer is capable of exceeding a mechanical or thermal index of 1.0, the
ultrasound imaging system displays indices starting from 0.4 in increments of 0.1 for all
displayed values.

A number of factors contribute to the estimation error for the displayed index. Variation
among transducers and systems, approximation for ‐time real index calculations, and
measurement errors contribute to the index display error. Measurement precision for
ultrasonic intensities, pressure, center frequency, & power is within 10%, 6%, 7% and 10%
respectively. The total estimated display accuracy is‐15%
+/ for MI and +/‐30% for TI.
Definitions for these parameters can be found in the AIUM/NEMA document entitled
Standard for Real‐Time Display of Thermal and Mechanical Aco ustic Output Indices on
Diagnostic Ultrasound Equipment (also known as the Output Display Standard)

Default Displayed MI and TI Values by Transducer


(Per transducer/mode that exceeds default MI or TI value of 0.4)

General Imaging

Mode of Operation
B M PW BC BCD THI
Transducer
MI TI MI TI MI TI MI TI MI TI MI TI
0.7 0.7 ‐ 0.5 0.2 ‐
C1‐6 0.9 0.7 0.9 0.7 ‐ ‐ 0.9 0.5 1.0 ‐ 0.7 ‐
4.3 4.3 ‐ 3.0 ‐ 1.9
‐ ‐ 0.5 0.7 ‐
0.5
L3‐12 0.8 ‐ 0.8 ‐ 0.8 1.0 0.5 0.7 ‐3. 0.7 ‐
‐1.0
1.2 1.2 2.1 7 0.8
2.7 2.7 0.6 3.0 2.0 3.8
SP1‐5 1.0 2.7 1.0 2.7 0.8 0.6 0.7 3.0 0.7 2.0 0.5 3.8
3.5 3.5 1.0 4.1 2.8 5.7

0.5 0.5 1.1 1.7 1.6 ‐


E3‐10 0.9 0.5 0.9 0.5 0.7 0.6 1.0 1.7 0.7 1.2 ‐ ‐
1.3 1.3 1.6 4.0 3.0 ‐
‐ ‐ 0.6 0.8 0.8 ‐
EN3‐10 0.7 ‐ 0.7 ‐ 0.5 ‐ 0.8 0.9 0.7 0.4 0.8 ‐
0.5 0.5 0.8 1.2 1.6 0.5

S: Soft Tissue Index, B: Bone Thermal Index, C: Cranial Thermal Index

227
Output range summary format
Transducer Model: L3‐12
System: E‐CUBE 7

Clinical Application Mode of Operation

B M PWD CWD Color Combined( Other


Doppler Specify) (Specify)
Max ISPTA.3

56.13 56.13 416.04 NA 485.47 459.98 NA

Min ISPTA.3

28.50 28.50 53.62 NA 38.30 275.01 NA

Max MI (or ISPPA.3)

1.33 1.33 0.57 NA 1.03 1.13 NA

Min MI (or ISPPA.3)

0.86 0.86 0.28 NA 0.39 0.43 NA

Max TIS

0.73 0.73 0.92 NA 1.87 2.14 NA

Min TIS

0.35 0.35 0.24 NA 0.62 0.79 NA

Max TIB

0.73 0.73 0.06 NA 1.87 1.08 NA

Min TIB

0.35 0.35 0.01 NA 0.62 0.23 NA

Max TIC

2.27 2.27 1.59 NA 4.24 4.49 NA

Min TIC

1.50 1.50 0.48 NA 1.83 2.72 NA

NA: Not Applicable

228
Transducer Model: C1-6
System: E‐CUBE 7

Clinical Application Mode of Operation

B M PWD CWD Color Combined( Other


Doppler Specify) (Specify)
Max ISPTA.3

113.80 113.80 466.81 NA 305.28 353.98 NA

Min ISPTA.3

23.47 23.47 317.33 NA 181.60 262.12 NA

Max MI (or ISPPA.3)

1.15 1.15 0.56 NA 1.16 0.63 NA

Min MI (or ISPPA.3)

0.68 0.68 0.32 NA 0.46 0.31 NA

Max TIS

2.54 2.54 1.07 NA 1.50 1.62 NA

Min TIS

0.28 0.28 0.06 NA 0.32 1.38 NA

Max TIB

2.54 2.54 2.08 NA 1.50 2.36 NA

Min TIB

0.28 0.28 0.08 NA 0.32 1.62 NA

Max TIC

6.00 6.00 3.97 NA 5.74 5.82 NA

Min TIC

1.98 1.98 0.14 NA 2.70 4.37 NA

NA: Not Applicable

229
Transducer Model: E3-10
System: E‐CUBE 7

Clinical Application Mode of Operation

B M PWD CWD Color Combined( Other


Doppler Specify) (Specify)
Max ISPTA.3

93.71 93.71 452.72 NA 462.51 471.06 NA

Min ISPTA.3

42.06 42.06 93.46 NA 103.99 70.21 NA

Max MI (or ISPPA.3)

1.19 1.19 0.54 NA 1.03 0.84 NA

Min MI (or ISPPA.3)

0.80 0.80 0.37 NA 0.38 0.26 NA

Max TIS

1.09 1.09 0.90 NA 1.05 2.09 NA

Min TIS

0.64 0.64 0.34 NA 0.38 0.60 NA

Max TIB

1.09 1.09 0.49 NA 1.05 1.54 NA

Min TIB

0.64 0.64 0.19 NA 0.38 0.49 NA

Max TIC

1.38 1.38 1.68 NA 1.42 4.72 NA

Min TIC

0.86 0.86 0.63 NA 0.75 1.05 NA

NA: Not Applicable

230
Transducer Model: EN-10
System: E‐CUBE 7

Clinical Application Mode of Operation

B M PWD CWD Color Combined( Other


Doppler Specify) (Specify)
Max ISPTA.3

52.91 52.91 201.25 NA 204.15 316.94 NA

Min ISPTA.3

21.18 21.18 134.93 NA 138.26 42.40 NA

Max MI (or ISPPA.3)

0.74 0.74 0.42 NA 0.76 0.78 NA

Min MI (or ISPPA.3)

0.56 0.56 0.33 NA 0.43 0.21 NA

Max TIS

0.68 0.68 1.01 NA 0.88 1.85 NA

Min TIS

0.11 0.11 0.28 NA 0.54 0.58 NA

Max TIB

0.68 0.68 0.04 NA 0.88 1.08 NA

Min TIB

0.11 0.11 0.02 NA 0.54 0.32 NA

Max TIC

0.67 0.67 2.03 NA 1.35 2.83 NA

Min TIC

0.42 0.42 0.59 NA 0.94 1.17 NA

NA: Not Applicable

231
Transducer Model: SP1‐5
System: E‐CUBE 7

Clinical Application Mode of Operation

B M PWD CWD Color Combined( Other


Doppler Specify) (Specify)
Max ISPTA.3
52.32 52.32 425.69 NA 224.06 495.60 NA

Min ISPTA.3
6.62 6.62 216.01 NA 174.52 170.46 NA

Max MI (or ISPPA.3)


1.14 1.14 0.53 NA 0.93 0.85 NA

Min MI (or ISPPA.3)


0.40 0.40 0.31 NA 0.54 0.42 NA

Max TIS
1.10 1.10 1.55 NA 0.96 5.39 NA

Min TIS
0.20 0.20 0.40 NA 0.48 2.62 NA

Max TIB
1.10 1.10 0.95 NA 0.96 2.24 NA

Min TIB
0.20 0.20 0.41 NA 0.48 1.12 NA

Max TIC
1.57 1.57 2.81 NA 1.23 5.94 NA

Min TIC
0.50 0.50 1.21 NA 0.72 4.24 NA

NA: Not Applicable

232
Acoustic output reporting table
Transducer Model: L3‐12
Operating Mode: B Mode
System: E‐CUBE 7
TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.33 0.73 - - - 2.27

IEC FDA Units

pra pr.3 MPa 3.13

P Wo mW 71.0 - - 71.0
min of
min of
[(W.3(Z1),ITA. -
Associated Acoustic Parameter

[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -

zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 1.40
deq(zb) deq(zsp) cm -
fawf fc MHz 5.59 5.83 - - - 5.83
X cm 0.96 - - - 0.96
Dim of Aaprt
Y cm 0.50 - - - 0.50

td PD μsec 0.26

prr PRF Hz 7680


Other Information

pr at max. Ipi pr@PIImax MPa 4.79


deq at max Ipi deq@PIImax cm -
FLX cm 9.00 - - 9.00
Focal length
FLY cm 2.00 - - 2.00
Ipa.α at
IPA.3@MImax W/cm2 333
max.MI

Frequency MHz 6.00 6.00 - - - 6.00


Control

Focal Zone cm 2.90 9.00 - - - 9.00


Conditions
Operating

Sample Volume Size cm - - - - - -

Power % 100 100 - - - 100

Mode type B B - - - B
Transducer Model: L3‐12

233
Operating Mode: THI Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.01 0.43 - - - 1.23

IEC FDA Units

pra pr.3 MPa 2.43

P Wo mW 38.4 - - 38.4

min of
min of
Associated Acoustic Parameter

[(W.3(Z1),ITA. -
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -

zbp zbp cm -

Zb zsp cm -

z at max.Ipi,α zsp cm 1.30

deq(zb) deq(zsp) cm -

fawf fc MHz 5.74 5.78 - - - 5.78

X cm 0.96 - - - 0.96
Dim of Aaprt
Y cm 0.50 - - - 0.50

td PD μsec 0.25

prr PRF Hz 6904


Other Information

pr at max. Ipi pr@PIImax MPa 3.10

deq at max Ipi deq@PIImax cm -

FLX cm 9.00 - - 9.00


Focal length
FLY cm 2.00 - - 2.00

Ipa.α at
IPA.3@MImax W/cm2 176
max.MI

Frequency MHz 5.60 5.60 - - - 5.60


Control Conditions

Focal Zone cm 4.40 9.00 - - - 9.00

Sample Volume Size cm - - - - - -

Power % 100 100 - - - 100


Operating

Mode type THI THI - - - THI

234
Transducer Model: L3‐12
Operating Mode: BC, BCD Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.13 2.14 - - - 4.24


IEC FDA Units

pra pr.3 MPa 2.78

P Wo mW 107 - - 43.7
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 1.40
deq(zb) deq(zsp) cm -
fawf fc MHz 6.06 6.16 - - - 6.15
X cm 0.54 - - - 0.63
Dim of Aaprt
Y cm 0.50 - - - 0.50

td PD μsec 0.24

prr PRF Hz 5260


Other Information

pr at max. Ipi pr@PIImax MPa 3.72


deq at max Ipi deq@PIImax cm -
FLX cm 3.30 - - 3.70
Focal length
FLY cm 2.00 - - 2.00
Ipa.α at
IPA.3@MImax W/cm2 288
max.MI

Frequency MHz 6.00 6.00 - - - 6.00


Control Conditions

Focal Zone cm 1.50 3.30 - - - 3.70

Sample Volume Size cm - - - - - -

Power % 100
Operating

100 - - - 100

Mode type BCD BCD BC

235
Transducer Model: L3‐12
Operating Mode: BD Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.34 1.12 - - - 2.78


IEC FDA Units

pra pr.3 MPa

P Wo mW 3.21
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

65.1 - - 65.1
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm -
deq(zb) deq(zsp) cm 1.90
fawf fc MHz -
X cm 5.75 6.16 - - - 6.16
Dim of Aaprt
Y cm 0.54 - - - 0.54

td PD μsec 0.50 - - - 0.50

prr PRF Hz 5440


Other Information

pr at max. Ipi pr@PIImax MPa 4.53


deq at max Ipi deq@PIImax cm -
FLX cm 3.30 - - 3.30
Focal length
FLY cm 2.00 - - 2.00
Ipa.α at
IPA.3@MImax W/cm2 308
max.MI

Frequency MHz 6.00 6.00 - - - 6.00


Control Conditions

Focal Zone cm 2.70 3.30 - - - 3.30

Sample Volume Size cm 0.00 1.50 - - - 1.50

Power %
Operating

100 100 - - - 100

Mode type BD BD - - - BD

236
Transducer Model: L3‐12
Operating Mode: D,M Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 0.57 - 0.92 - 0.06 1.59


IEC FDA Units

pra pr.3 MPa 1.28

P Wo mW - 39.2 37.3 37.3


min of
min of
[(W.3(Z1),ITA. -
Associated Acoustic Parameter

[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm 1.60
z at max.Ipi,α zsp cm 1.30
deq(zb) deq(zsp) cm 0.39
fawf fc MHz 5.06 - 6.16 - 6.16 6.16
X cm - 0.72 - 0.54 0.54
Dim of Aaprt
Y cm - 0.50 - 0.50 0.50

td PD μsec 1.48

prr PRF Hz 4130


Other Information

pr at max. Ipi pr@PIImax MPa 1.64


deq at max Ipi deq@PIImax cm 0.32
FLX cm - 4.40 - 3.30
Focal length
FLY cm - 2.00 - 2.00
Ipa.α at
IPA.3@MImax W/cm2 68.1
max.MI

Frequency MHz 5.00 - 6.00 - 6.00 6.00


Control Conditions

Focal Zone cm 1.10 - 4.40 - 3.30 3.30

Sample Volume Size cm 1.50 - 1.50 - 1.50 1.50

Power %
Operating

100 - 100 - 100 100

Mode type D Only - D Only - D Only D Only

237
Transducer Model: C1-6
Operating Mode: B Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.15 2.54 - - - 6.00


IEC FDA Units

pra pr.3 MPa 1.75

P Wo mW 276 - - 249
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 4.50
deq(zb) deq(zsp) cm -
fawf fc MHz 2.34 2.89 - - - 2.70
X cm 0.77 - - - 0.62
Dim of Aaprt
Y cm 1.35 - - - 1.35

td PD μsec 0.54

prr PRF Hz 5078


Other Information

pr at max. Ipi pr@PIImax MPa 2.55


deq at max Ipi deq@PIImax cm -
FLX cm 8.00 - - 6.50
Focal length
FLY cm 7.50 - - 7.50
Ipa.α at
IPA.3@MImax W/cm2 122
max.MI

Frequency MHz 2.50 4.50 - - - 4.50


Control Conditions

Focal Zone cm 8.00 8.00 - - - 6.50

Sample Volume Size cm - - - - - -

Power %
Operating

100 100 - - - 100

Mode type B B - - - B

238
Transducer Model: C1-6
Operating Mode: THI Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.10 1.02 - - - 3.31


IEC FDA Units

pra pr.3 MPa 1.64

P Wo mW 142 - - 137
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 4.50
deq(zb) deq(zsp) cm -
fawf fc MHz 2.24 2.24 - - - 2.21
X cm 0.77 - - - 0.62
Dim of Aaprt
Y cm 1.35 - - - 1.35

td PD μsec 0.57

prr PRF Hz 2580


Other Information

pr at max. Ipi pr@PIImax MPa 2.30


deq at max Ipi deq@PIImax cm -
FLX cm 8.00 - - 6.50
Focal length
FLY cm 7.50 - - 7.50
Ipa.α at
IPA.3@MImax W/cm2 107
max.MI

Frequency MHz 2.20 2.20 - - - 2.20


Control Conditions

Focal Zone cm 8.00 8.00 - - - 6.50

Sample Volume Size cm - - - - - -

Power %
Operating

100 100 - - - 100

Mode type THI THI - - - THI

239
Transducer Model: C1-6
Operating Mode: BC, BCD Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.16 1.62 - - - 5.74


IEC FDA Units

pra pr.3 MPa 1.78

P Wo mW 341 - - 344
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 4.30
deq(zb) deq(zsp) cm -
fawf fc MHz 2.35 2.01 - - - 2.47
X cm 1.54 - - - 1.34
Dim of Aaprt
Y cm 1.35 - - - 1.35

td PD μsec 0.54

prr PRF Hz 2253


Other Information

pr at max. Ipi pr@PIImax MPa 2.56


deq at max Ipi deq@PIImax cm -
FLX cm 26.4 - - 13.0
Focal length
FLY cm 7.50 - - 7.50
Ipa.α at
IPA.3@MImax W/cm2 120
max.MI

Frequency MHz 2.50 2.00 - - - 2.50


Control Conditions

Focal Zone cm 7.70 26.4 - - - 13.0

Sample Volume Size cm - - - - - -

Power %
Operating

100 100 - - - 100

Mode type BC BCD - - - BC

240
Transducer Model: C1-6
Operating Mode: BD Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 0.63 1.83 - - - 3.97


IEC FDA Units

pra pr.3 MPa 1.06

P Wo mW 398 - - 464
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 1.20
deq(zb) deq(zsp) cm -
fawf fc MHz 2.84 2.01 - - - 2.95
X cm 1.54 - - - 1.54
Dim of Aaprt
Y cm 1.35 - - - 1.35

td PD μsec 0.42

prr PRF Hz 2253


Other Information

pr at max. Ipi pr@PIImax MPa 1.85


deq at max Ipi deq@PIImax cm -
FLX cm 26.4 - - 23.1
Focal length
FLY cm 7.50 - - 7.50
Ipa.α at
IPA.3@MImax W/cm2 39.1
max.MI

Frequency MHz 4.50 2.00 - - - 3.00


Control Conditions

Focal Zone cm 23.0 26.4 - - - 23.1

Sample Volume Size cm 0.00 1.50 - - - 1.50

Power %
Operating

100 100 - - - 100

Mode type BD BD - - - BD

241
Transducer Model: C1-6
Operating Mode: D, M Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 0.56 - - 1.07 2.08 3.97


IEC FDA Units

pra pr.3 MPa 0.80

P Wo mW - - 96.6 258
min of
min of
[(W.3(Z1),ITA. 195
Associated Acoustic Parameter

[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm 1.20
zbp zbp cm 2.44
Zb zsp cm 4.60
z at max.Ipi,α zsp cm 4.60
deq(zb) deq(zsp) cm 0.38
fawf fc MHz 2.02 - - 2.95 2.02 2.95
X cm - - 1.54 0.67 1.54
Dim of Aaprt
Y cm - - 1.35 1.35 1.35

td PD μsec 3.86

prr PRF Hz 4130


Other Information

pr at max. Ipi pr@PIImax MPa 1.09


deq at max Ipi deq@PIImax cm 0.36
FLX cm - - 23.1 23.1
Focal length
FLY cm - - 7.50 7.50
Ipa.α at
IPA.3@MImax W/cm2 29.1
max.MI

Frequency MHz 2.00 - - 3.00 2.00 3.00


Control Conditions

Focal Zone cm 6.60 - - 23.1 6.60 23.1

Sample Volume Size cm 1.50 - - 1.50 1.50 1.50

Power %
Operating

100 - - 100 100 100

Mode type D Only - - D Only D Only D Only

242
Transducer Model: E3-10
Operating Mode: B Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.19 1.09 - - - 1.38


IEC FDA Units

pra pr.3 MPa 2.65

P Wo mW 34.7 - - 32.7
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 1.80
deq(zb) deq(zsp) cm -
fawf fc MHz 4.94 5.41 - - - 4.94
X cm 0.64 - - - 0.46
Dim of Aaprt
Y cm 0.60 - - - 0.60

td PD μsec 0.21

prr PRF Hz 2160


Other Information

pr at max. Ipi pr@PIImax MPa 3.65


deq at max Ipi deq@PIImax cm -
FLX cm 13.5 - - 3.60
Focal length
FLY cm 3.50 - - 3.50
Ipa.α at
IPA.3@MImax W/cm2 215
max.MI

Frequency MHz 6.70 8.50 - - - 6.70


Control Conditions

Focal Zone cm 3.60 13.5 - - - 3.60

Sample Volume Size cm - - - - - -

Power %
Operating

100 100 - - - 100

Mode type B B - - - B

243
Transducer Model: E3-10
Operating Mode: THI Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.29 0.75 - - - 1.39


IEC FDA Units

pra pr.3 MPa 2.76

P Wo mW 34.6 - - 38.9
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 1.80
deq(zb) deq(zsp) cm -
fawf fc MHz 4.56 4.32 - - - 4.26
X cm 0.64 - - - 0.64
Dim of Aaprt
Y cm 0.60 - - - 0.60

td PD μsec 0.28

prr PRF Hz 5340


Other Information

pr at max. Ipi pr@PIImax MPa 3.54


deq at max Ipi deq@PIImax cm -
FLX cm 6.30 - - 8.30
Focal length
FLY cm 3.50 - - 3.50
Ipa.α at
IPA.3@MImax W/cm2 223
max.MI

Frequency MHz 4.50 4.50 - - - 3.80


Control Conditions

Focal Zone cm 3.60 6.30 - - - 8.30

Sample Volume Size cm - - - - - -

Power %
Operating

100 100 - - - 100

Mode type THI THI - - - THI

244
Transducer Model: E3-10
Operating Mode: BC, BCD Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.03 2.09 - - - 1.54


IEC FDA Units

pra pr.3 MPa 2.27

P Wo mW 88.6 - - 88.6
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 1.80
deq(zb) deq(zsp) cm -
fawf fc MHz 4.86 5.00 - - - 5.00
X cm 0.26 - - - 0.26
Dim of Aaprt
Y cm 0.60 - - - 0.60

td PD μsec 0.27

prr PRF Hz 4187


Other Information

pr at max. Ipi pr@PIImax MPa 3.13


deq at max Ipi deq@PIImax cm -
FLX cm 1.50 - - 1.50
Focal length
FLY cm 3.50 - - 3.50
Ipa.α at
IPA.3@MImax W/cm2 169
max.MI

Frequency MHz 5.00 5.00 - - - 5.00


Control Conditions

Focal Zone cm 3.60 1.50 - - - 1.50

Sample Volume Size cm - - - - - -

Power %
Operating

100 100 - - - 100

Mode type BC BCD - - - BCD

245
Transducer Model: E3-10
Operating Mode: BD Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 0.88 1.47 - - - 3.16


IEC FDA Units

pra pr.3 MPa 2.00

P Wo mW 56.2 - - 56.2
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 1.80
deq(zb) deq(zsp) cm -
fawf fc MHz 5.13 5.00 - - - 5.00
X cm 0.26 - - - 0.26
Dim of Aaprt
Y cm 0.60 - - - 0.60

td PD μsec 0.20

prr PRF Hz 4069


Other Information

pr at max. Ipi pr@PIImax MPa 2.76


deq at max Ipi deq@PIImax cm -
FLX cm 1.50 - - 1.50
Focal length
FLY cm 3.50 - - 3.50
Ipa.α at
IPA.3@MImax W/cm2 120
max.MI

Frequency MHz 6.70 5.00 - - - 5.00


Control Conditions

Focal Zone cm 3.60 1.50 - - - 1.50

Sample Volume Size cm 0.00 1.50 - - - 1.50

Power %
Operating

100 100 - - - 100

Mode type BD BD - - - BD

246
Transducer Model: E3-10
Operating Mode: D, M Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 0.54 - 0.90 - 0.49 1.68


IEC FDA Units

pra pr.3 MPa 1.21

P Wo mW - 46.8 28.8 46.8


min of
min of
[(W.3(Z1),ITA. -
Associated Acoustic Parameter

[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm 2.30
z at max.Ipi,α zsp cm 2.90
deq(zb) deq(zsp) cm 0.26
fawf fc MHz 4.98 - 6.16 - 5.33 6.16
X cm - 0.64 - 0.46 0.64
Dim of Aaprt
Y cm - 0.60 - 0.60 0.60

td PD μsec 1.37

prr PRF Hz 4130


Other Information

pr at max. Ipi pr@PIImax MPa 2.01


deq at max Ipi deq@PIImax cm 0.24
FLX cm - 10.5 - 10.5
Focal length
FLY cm - 3.50 - 3.50
Ipa.α at
IPA.3@MImax W/cm2 80.1
max.MI

Frequency MHz 5.00 - 6.00 - 5.50 6.00


Control Conditions

Focal Zone cm 4.50 - 10.5 - 3.00 10.5

Sample Volume Size cm 1.50 - 1.50 - 1.50 1.50

Power %
Operating

100 - 100 - 100 100

Mode type D Only - D Only - D Only D Only

247
Transducer Model: EN3-10
Operating Mode: B Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 0.74 0.68 - - - 0.67


IEC FDA Units

pra pr.3 MPa 1.72

P Wo mW 19.0 - - 19.0
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 1.80
deq(zb) deq(zsp) cm -
fawf fc MHz 5.40 5.47 - - - 5.47
X cm 0.66 - - - 0.66
Dim of Aaprt
Y cm 0.60 - - - 0.60

td PD μsec 0.22

prr PRF Hz 2160


Other Information

pr at max. Ipi pr@PIImax MPa 2.55


deq at max Ipi deq@PIImax cm -
FLX cm 6.30 - - 6.30
Focal length
FLY cm 2.20 - - 2.20
Ipa.α at
IPA.3@MImax W/cm2 106
max.MI

Frequency MHz 6.70 6.70 - - - 6.70


Control Conditions

Focal Zone cm 3.60 6.30 - - - 6.30

Sample Volume Size cm - - - - - -

Power %
Operating

100 100 - - - 100

Mode type B B - - - B

248
Transducer Model: EN3-10
Operating Mode: THI Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 0.66 0.38 - - - 0.61


IEC FDA Units

pra pr.3 MPa 1.42

P Wo mW 16.7 - - 17.2
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 1.90
deq(zb) deq(zsp) cm -
fawf fc MHz 4.65 4.49 - - - 4.45
X cm 0.66 - - - 0.66
Dim of Aaprt
Y cm 0.60 - - - 0.60

td PD μsec 0.28

prr PRF Hz 4836


Other Information

pr at max. Ipi pr@PIImax MPa 1.88


deq at max Ipi deq@PIImax cm -
FLX cm 13.5 - - 10.6
Focal length
FLY cm 2.20 - - 2.20
Ipa.α at
IPA.3@MImax W/cm2 71.0
max.MI

Frequency MHz 4.50 3.80 - - - 3.80


Control Conditions

Focal Zone cm 8.30 13.5 - - - 10.6

Sample Volume Size cm - - - - - -

Power %
Operating

100 100 - - - 100

Mode type THI THI - - - THI

249
Transducer Model: EN3-10
Operating Mode: BC, BCD Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 0.78 1.85 - - - 1.35


IEC FDA Units

pra pr.3 MPa 1.87

P Wo mW 78.2 - - 38.2
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 1.80
deq(zb) deq(zsp) cm -
fawf fc MHz 5.74 5.32 - - - 5.27
X cm 0.66 - - - 0.66
Dim of Aaprt
Y cm 0.60 - - - 0.60

td PD μsec 0.22

prr PRF Hz 3360


Other Information

pr at max. Ipi pr@PIImax MPa 2.44


deq at max Ipi deq@PIImax cm -
FLX cm 12.0 - - 10.6
Focal length
FLY cm 2.20 - - 2.20
Ipa.α at
IPA.3@MImax W/cm2 107
max.MI

Frequency MHz 6.70 5.50 - - - 5.50


Control Conditions

Focal Zone cm 2.00 12.0 - - - 10.6

Sample Volume Size cm - - - - - -

Power %
Operating

100 100 - - - 100

Mode type BCD BCD - - - BC

250
Transducer Model: EN3-10
Operating Mode: BD Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 0.87 1.68 - - - 2.55


IEC FDA Units

pra pr.3 MPa 1.92

P Wo mW 72.2 - - 72.2
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 1.70
deq(zb) deq(zsp) cm -
fawf fc MHz 4.87 5.32 - - - 5.32
X cm 0.66 - - - 0.66
Dim of Aaprt
Y cm 0.60 - - - 0.60

td PD μsec 0.26

prr PRF Hz 4069


Other Information

pr at max. Ipi pr@PIImax MPa 2.59


deq at max Ipi deq@PIImax cm -
FLX cm 10.5 - - 10.5
Focal length
FLY cm 2.20 - - 2.20
Ipa.α at
IPA.3@MImax W/cm2 136
max.MI

Frequency MHz 5.00 5.50 - - - 5.50


Control Conditions

Focal Zone cm 2.00 10.5 - - - 10.5

Sample Volume Size cm 0.00 1.50 - - - 1.50

Power %
Operating

100 100 - - - 100

Mode type BD BD - - - BD

251
Transducer Model: EN3-10
Operating Mode: D, M Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 0.42 - 1.01 - 0.04 2.03


IEC FDA Units

pra pr.3 MPa 0.98

P Wo mW - 36.7 36.7 36.7


min of
min of
[(W.3(Z1),ITA. -
Associated Acoustic Parameter

[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm 2.00
z at max.Ipi,α zsp cm 2.00
deq(zb) deq(zsp) cm 0.39
fawf fc MHz 5.32 - 5.32 - 5.32 5.32
X cm - 0.27 - 0.27 0.27
Dim of Aaprt
Y cm - 0.60 - 0.60 0.60

td PD μsec 1.40

prr PRF Hz 2130


Other Information

pr at max. Ipi pr@PIImax MPa 1.37


deq at max Ipi deq@PIImax cm 0.38
FLX cm - 1.50 - 1.50
Focal length
FLY cm - 2.20 - 2.20
Ipa.α at
IPA.3@MImax W/cm2 50.0
max.MI

Frequency MHz 5.50 - 5.50 - 5.50 5.50


Control Conditions

Focal Zone cm 1.50 - 1.50 - 1.50 1.50

Sample Volume Size cm 1.50 - 1.50 - 1.50 1.50

Power %
Operating

100 - 100 - 100 100

Mode type D Only - D Only - D Only D Only

252
Transducer Model: SP1-5
Operating Mode: B Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.14 1.10 - - - 1.57


IEC FDA Units

pra pr.3 MPa 1.67

P Wo mW 80.5 - - 80.5
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 4.90
deq(zb) deq(zsp) cm -
fawf fc MHz 2.13 2.06 - - - 2.06
X cm 0.96 - - - 0.96
Dim of Aaprt
Y cm 1.35 - - - 1.35

td PD μsec 0.55

prr PRF Hz 3420


Other Information

pr at max. Ipi pr@PIImax MPa 2.42


deq at max Ipi deq@PIImax cm -
FLX cm 14.0 - - 14.0
Focal length
FLY cm 7.00 - - 7.00
Ipa.α at
IPA.3@MImax W/cm2 99.0
max.MI

Frequency MHz 3.50 2.50 - - - 2.50


Control Conditions

Focal Zone cm 8.00 14.0 - - - 14.0

Sample Volume Size cm - - - - - -

Power %
Operating

100 100 - - - 100

Mode type B B - - - B

253
Transducer Model: SP1-5
Operating Mode: THI Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.38 1.21 - - - 1.78


IEC FDA Units

pra pr.3 MPa 1.93

P Wo mW 91.3 - - 91.3
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 4.60
deq(zb) deq(zsp) cm -
fawf fc MHz 1.95 1.95 - - - 1.95
X cm 0.96 - - - 0.96
Dim of Aaprt
Y cm 1.35 - - - 1.35

td PD μsec 0.98

prr PRF Hz 3420


Other Information

pr at max. Ipi pr@PIImax MPa 2.52


deq at max Ipi deq@PIImax cm -
FLX cm 14.0 - - 14.0
Focal length
FLY cm 7.00 - - 7.00
Ipa.α at
IPA.3@MImax W/cm2 258
max.MI

Frequency MHz 2.00 2.00 - - - 2.00


Control Conditions

Focal Zone cm 14.0 14.0 - - - 14.0

Sample Volume Size cm - - - - - -

Power %
Operating

100 100 - - - 100

Mode type THI THI - - - THI

254
Transducer Model: SP1-5
Operating Mode: BC, BCD Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 0.93 5.39 - - - 2.24


IEC FDA Units

pra pr.3 MPa 1.44

P Wo mW 345 - - 275
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 6.10
deq(zb) deq(zsp) cm -
fawf fc MHz 2.37 2.95 - - - 2.00
X cm 0.96 - - - 0.63
Dim of Aaprt
Y cm 1.35 - - - 1.35

td PD μsec 1.48

prr PRF Hz 330


Other Information

pr at max. Ipi pr@PIImax MPa 2.37


deq at max Ipi deq@PIImax cm -
FLX cm 9.90 - - 3.30
Focal length
FLY cm 7.00 - - 7.00
Ipa.α at
IPA.3@MImax W/cm2 182
max.MI

Frequency MHz 2.50 3.00 - - - 2.00


Control Conditions

Focal Zone cm 7.00 9.90 - - - 3.30

Sample Volume Size cm - - - - - -

Power %
Operating

100 100 - - - 100

Mode type BC BCD - - - BCD

255
Transducer Model: SP1-5
Operating Mode: BD Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 1.07 5.13 - - - 2.81


IEC FDA Units

pra pr.3 MPa 1.55

P Wo mW 325 - - 331
min of
min of
[(W.3(Z1),ITA.
Associated Acoustic Parameter

-
[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm -
z at max.Ipi,α zsp cm 4.30
deq(zb) deq(zsp) cm -
fawf fc MHz 2.09 2.95 - - - 2.00
X cm 0.96 - - - 0.96
Dim of Aaprt
Y cm 1.35 - - - 1.35

td PD μsec 0.57

prr PRF Hz 2207


Other Information

pr at max. Ipi pr@PIImax MPa 2.15


deq at max Ipi deq@PIImax cm -
FLX cm 6.60 - - 9.90
Focal length
FLY cm 7.00 - - 7.00
Ipa.α at
IPA.3@MImax W/cm2 64.4
max.MI

Frequency MHz 3.50 3.00 - - - 2.00


Control Conditions

Focal Zone cm 7.00 6.60 - - - 9.90

Sample Volume Size cm 0.00 1.50 - - - 1.50

Power %
Operating

100 100 - - - 100

Mode type BD BD - - - BD

256
Transducer Model: SP1-5
Operating Mode: D, M Mode
System: E‐CUBE 7

TIS TIB
Index label MI non-scan TIC
scan non-scan
A aprt≤ 1 A aprt >1

Global Maximum: Index Value 0.53 - 1.55 - 0.95 2.81


IEC FDA Units

pra pr.3 MPa 0.92

P Wo mW - 72.3 72.3 72.3


min of
min of
[(W.3(Z1),ITA. -
Associated Acoustic Parameter

[Pα(zs),Ita.α (zs)]
3(z1))]

zs z1 cm -
zbp zbp cm -
Zb zsp cm 2.90
z at max.Ipi,α zsp cm 2.90
deq(zb) deq(zsp) cm 0.42
fawf fc MHz 2.95 - 2.95 - 2.95 2.95
X cm - 0.24 - 0.24 0.24
Dim of Aaprt
Y cm - 1.35 - 1.35 1.35

td PD μsec 2.64

prr PRF Hz 4130


Other Information

pr at max. Ipi pr@PIImax MPa 1.22


deq at max Ipi deq@PIImax cm 0.42
FLX cm - 3.30 - 3.30
Focal length
FLY cm - 7.00 - 7.00
Ipa.α at
IPA.3@MImax W/cm2 26.5
max.MI

Frequency MHz 3.00 - 3.00 - 3.00 3.00


Control Conditions

Focal Zone cm 3.30 - 3.30 - 3.30 3.30

Sample Volume Size cm 1.50 - 1.50 - 1.50 1.50

Power %
Operating

100 - 100 - 100 100

Mode type D Only - D Only - D Only D Only

257
8-9 Peripheral Update for EC Countries
The following is intended to provide the users in EC countries with updated information
concerning the connection of the E-CUBE 7 to image recording and other devices or
communication networks.

The E-CUBE 7 has been verified for overall safety, compatibility and compliance with the
following on-board image recording devices:

 Color Printer
Manufacturer: Sony Corporation, Mitsubishi Electric Corporation
Model: Sony Digital UP-D21MD, Sony Analog UP-25MD

 BW Printer
Manufacturer: Sony Corporation, Mitsubishi Electric Corporation
Model: Sony Digital UP-D897, Sony Analog UP-897MD, Mitsubishi P95DE

 DVR
Manufacturer: Sony Corporation
Model: Digital DVO-1000MD

The E-CUBE 7 may also be used safely while connected to devices other than those
recommended above if the devices and their specifications, installation, and interconnection
with the system conform to the requirements of IEC/EN 60601-1-1.

258
8-9-1 Basic accessories
Depending on the console type you purchase, the basic accessories provided with the console
may differ.

E-CUBE 7 Standard
E-CUBE 7/7-T console
User manual CD/hard copy (English)
Quick guide (English hard copy)
Sonic gel

8-9-2 Optional supplies and accessories


The following table list shows optional supplies and accessories that have been verified to be
compatible with the system.

Console accessory

Tri-pedal footswitch

Transducer

C1-6

E3-10

EN3-10

L3-12

SP1-5

259
Disinfectant

Cidex OPA

Cidex Plus

Biopsy kit

SC1-6 Biopsy Starter kit (for C1-6)

L3-12 Biopsy starter kit

E3‐10 Disposable Needle Guide

E3‐10 Reusable Needle Guide

EN3‐10 Disposable Needle Guide

EN3‐10 Reusable Needle Guide

Software

Full SRI

Xpeed

Spatial compounding

Frequency compounding

FTHI (Filtered Tissue Harmonic)

DICOM 3.0 Connectivity

DICOM SR(OB)

CV M&R Standard

CV M&R Professional

Panoramic

Auto IMT Measurement

Anatomical-M

260
1

SERVICE MANUAL
Rev. 1 (ENG)

You might also like